Cytomics FC 500 MPL With MXP Software
System Administrator’s Guide
PN 628899BB (October 2011)
Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821
WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER-TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT. DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS. ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER’S RECOMMENDATIONS. IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION, CONTACT YOUR BECKMAN COULTER REPRESENTATIVE. HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS, CAUTIONS, and IMPORTANTS alert you as follows: WARNING - Can cause injury. CAUTION - Can cause damage to the instrument. IMPORTANT - Can cause misleading results. BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. WARNING Risk of operator injury if: r All doors, covers and panels are not closed and secured in place prior to and during instrument operation. r The integrity of safety interlocks and sensors is compromised. r Instrument alarms and error messages are not acknowledged and acted upon. r You contact moving parts. r You mishandle broken parts. r Doors, covers and panels are not opened, closed, removed and/or replaced with care. r Improper tools are used for troubleshooting. To avoid injury: r Keep doors, covers and panels closed and secured in place while the instrument is in use. r Take full advantage of the safety features of the instrument. Do not defeat safety interlocks and sensors. r Acknowledge and act upon instrument alarms and error messages. r Keep away from moving parts. r Report any broken parts to your Beckman Coulter Representative. r Open/remove and close/replace doors, covers and panels with care. r Use the proper tools when troubleshooting. CAUTION System integrity might be compromised and operational failures might occur if: r This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s computer with software authorized by Beckman Coulter. r You install software that is not an original copyrighted version. Only use software that is an original copyrighted version to prevent virus contamination. IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor, and, if it is not presently under a Beckman Coulter service maintenance agreement, Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product. If you purchased this product from a third party and would like further information concerning this topic, call your Beckman Coulter Representative.
REVISION STATUS Issue A, Initial Issue, 11/04 MXP Software Version 2.0. Initial issue for customer distribution. Revision B, 08/08 MXP Software Version 2.2. Page 1-1 has been updated to indicate that the MXP 2.2 Software can run in Windows 2000 or Windows XP operating systems. Revision BA, 03/10 MXP Software Version 2.2. The Installation chapter has been updated to remove MXP software installation instruction. The MXP software is now factory installed. Revision BB, 10/11 MXP Software Version 2.2. (Analysis or Cytometer) Updates were made on pages xi and 2-3. Note: Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page.
This document applies to the latest software listed and higher versions. When a subsequent software version changes the information in this document, a new issue will be released to the Beckman Coulter website. For labeling updates, go to www.beckmancoulter.com and download the most recent manual or system help for your instrument.
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REVISION STATUS
iv
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CONTENTS WARNINGS AND PRECAUTIONS REVISION STATUS, iii INTRODUCTION, xi USING YOUR Cytomics FC 500 MPL MANUALS, xi ABOUT THIS MANUAL, xi CONVENTIONS, xii To Choose A Command With The Keyboard, xiii Dialog Box, xiii Description of Reporting Units, xiii GRAPHICS, xiii COMPUTER PROGRAM STATEMENT, xiii 1
2
INSTALLATION, 1-1 1.1
INSTALLING MICROSOFT EXCEL SOFTWARE, 1-1
1.2
INSTALLING MXP SOFTWARE, 1-1 Preinstallation Checks, 1-1 Installing The 21 CFR Part 11 Option Disk, 1-1 If the CD-ROM Does Not Autorun, 1-5
ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION, 2-1 2.1
OVERVIEW, 2-1 MXP Software System Administrator Guide Availability, 2-1 Online, 2-1 PDF Files, 2-1 MXP Software with 21 CFR Part 11 Option, 2-2 Passwords, 2-2 Audit Trails, 2-3 Electronic Signatures, 2-3 Archiving, 2-3 DaCS Software, 2-3 DaCS Administrator Manual, 2-3
2.2
MULTI-USER SIGN ON, 2-4 Plate Display, 2-4 Startup Wizard, 2-4 User ID, 2-6 Logged In, 2-6 Log Into and Log Out of DaCS Software, 2-6 Password, 2-6 Admin Button, 2-6 Finish Button, 2-6 Help Button, 2-6
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CONTENTS
2.3
SIGN-ON ADMINISTRATION, 2-7 User Administration Screen, 2-7 Add User, 2-7 Delete User, 2-7 Modify User, 2-7 Workgroups, 2-8 Export Log, 2-8 View Audit Trail, 2-8 Change Default Save Comments, 2-8 Archive Data, 2-8 Restore Archive, 2-8 Recover File from Archive, 2-8 Auto-Logout Timeout, 2-8 Password Timeout, 2-9 Password Failure Attempts, 2-9 Cytometer Serial Number, 2-9
2.4
SETTING UP WORKGROUPS, 2-9 Workgroup Selection, 2-9 Users, 2-10 Edit Button, 2-10 Edit Workgroups, 2-10 Add, 2-10 Delete, 2-10
2.5
EXPORT BILLING INFORMATION, 2-11
2.6
VIEWING AND PRINTING AUDIT TRAILS, 2-13 Procedure, 2-14
2.7
CHANGING DEFAULT SAVE COMMENTS, 2-17 Procedure, 2-17
2.8
ARCHIVING DATA, 2-19 Archive Location, 2-19 Archive Criteria, 2-19 Precautions, 2-19 Archive By Date, 2-20 Archive Histogram, Panel, Protocol or PDF Files, 2-20 Archive LMD Files By, 2-21 Procedure, 2-21
2.9
RESTORING ARCHIVED DATA, 2-25
2.10 RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE, 2-27 Procedure, 2-27 2.11 USER PROFILE – USER ID, 2-29 User ID, 2-30 First Name, 2-30 Last Name, 2-30
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CONTENTS
Title/Description, 2-30 Training Info, 2-30 User Trained?, 2-30 Date Trained, 2-30 By Whom, 2-30 Privileges, 2-30 Access other files?, 2-30 Remember last accessed LMD directory?, 2-30 Overwrite acquired data files?, 2-30 Overwrite other data files?, 2-31 Add Absolute Calibration Batches, 2-31 Can Modify Custom Dyes?, 2-31 Status, 2-31 Change This User’s Password, 2-31 Print User Information, 2-32 2.12 USER PROFILE – PATHS, 2-33 Browsing Button, 2-33 Home, 2-33 Path Details, 2-33 Backup, 2-33 2.13 DaCS SOFTWARE, 2-34 Setting Up User IDs, 2-34 MXP Software User IDs, 2-34 DaCS Users For Use Outside MXP Software, 2-34 3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE, 3-1 3.1
OVERVIEW, 3-1 MXP Software System Administrator Guide Availability, 3-1 Online, 3-1 PDF Files, 3-1
3.2
MULTI-USER SIGN ON, 3-2 Plate Display, 3-2 Startup Wizard, 3-2 User ID, 3-3 Logged In, 3-3 Password, 3-4 Admin Button, 3-4 Finish Button, 3-4 Help Button, 3-4
3.3
SIGN-ON ADMINISTRATION, 3-5 User Administration Screen, 3-5 Add User, 3-5 Delete User, 3-5 Modify User, 3-6 Workgroups, 3-6 Workgroup Selection, 3-6
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CONTENTS
Users, 3-6 Edit Button, 3-6 Edit Workgroups, 3-7 Add, 3-7 Delete, 3-7 Export Billing Information, 3-8 View Audit Trail, 3-10 Change Default Save Comments, 3-10 Archive Data, 3-10 Restore Archive, 3-10 Recover File From Archive, 3-10 Auto-Logout Timeout, 3-10 Password Timeout, 3-10 Password Failure Attempts, 3-10 Cytometer Serial Number, 3-10 3.4
USER PROFILE – USER ID, 3-11 User ID, 3-11 First Name, 3-12 Last Name, 3-12 Title/Description, 3-12 Training Info, 3-12 Privileges, 3-12 Access other files?, 3-12 Remember last accessed LMD directory?, 3-12 Overwrite acquired data files?, 3-12 Overwrite other data files?, 3-12 Add Absolute Calibration Batches, 3-13 Can Modify Custom Dyes?, 3-13 Status, 3-13 Change This User’s Password, 3-13 Print User Information, 3-14
3.5
USER PROFILE – PATHS, 3-15 Browsing Buttons, 3-15 Home, 3-15 Path Details, 3-15 Backup, 3-16
INDEX TRADEMARKS
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CONTENTS
TABLES 2.1
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Audit Trail Activity Types, 2-13
ix
CONTENTS
x
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INTRODUCTION This introductory section contains the following topics: r
USING YOUR Cytomics FC 500 MPL MANUALS
r
ABOUT THIS MANUAL
r
CONVENTIONS, and
r
GRAPHICS.
USING YOUR Cytomics FC 500 MPL MANUALS The manuals listed below are available as PDF files in the FC 500 MPL MXP software. Printed versions of these manuals are also available by order. Use the Reference manual for instrument specifications and information on installation and system options. Use the Instructions For Use manual for the day-to-day running of your instrument. Go through the detailed step-by-step procedures of startup, quality control (QC), running samples, analyzing data, printing reports, reviewing QC data, and shutdown. It contains safety and troubleshooting information, error messages, as well as in-depth information on the principles of flow cytometry, information about what your instrument does, and the methods it uses. Use the Special Procedures manual to clean, replace, or adjust a component of the instrument. Use the System Administrator’s Guide to add and edit user profiles including their User IDs and privileges. If you have the 21 CFR Part 11 optional software, as part of your laboratory’s responsibility for compliance: 1) only the System Administrator should have access to and use the System Administrator’s Guide, 2) the CD-ROM containing the System Administrator’s Guide should be protected from access by non-administrator personnel.
ABOUT THIS MANUAL The information in your FC 500 MPL System Administrator’s Guide is organized as follows:
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s
Chapter 1, INSTALLATION Provides detailed instructions how to install the MXP software and how to install the Add-Ins to the Microsoft Excel (version 2002 or 2003 only) software.
s
Chapter 2, ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION Describes how to use the System Administrator screens if your system has the 21 CFR Part 11 option installed.
s
Chapter 3, ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE Describes how to use the System Administrator screens for systems that have the standard MXP software, version 2.2 (without the 21 CFR Part 11 option installed).
s
INDEX Provides page numbers for indexed information.
xi
INTRODUCTION CONVENTIONS
CONVENTIONS This manual uses the following conventions: r
Throughout this manual your FC 500 MPL is also referred to as the system or instrument.
r
Bold font indicates a software option, such as Cytometer.
r
Italics font indicates screen text displayed on the instrument, such as Preparing Samples.
r
Courier font indicates text you have to type using the keyboard.
r
ë indicates a key (such as Û).
r
ë+ë indicates that the two keys listed (such as Þ+Ê) are linked for a specific function and must be pressed in this sequence: a.
Press down on the first key listed and while continuing to press it, press down on the second key listed.
b.
Release both keys at the same time.
r
ë ë indicates to press and release the first key listed then press and release the next key listed. For example: Y Û.
r
Icons/buttons to select functions on the software screen are shown within text. Example:
. indicates to use the mouse to select the screen button labeled
r . r
xii
File tt Save indicates to use the mouse to select the Save item on the File menu.
r
É through Ô are special function keys.
r
A Note contains information that is important to remember or helpful in performing a procedure.
r
The terms “screen” and “window” are used interchangeably.
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INTRODUCTION GRAPHICS
To Choose A Command With The Keyboard After you press Þ, each menu name has one letter underlined to indicate which letter to use to pull down the menu. For example, the letter F in the File menu is underlined, press F to pull down the File menu; the letter E in the Edit menu is underlined, press E to pull down the Edit menu. Command
Function
Û
Accepts your selection.
È
Stops the operation, discarding your choices.
Ù
Moves cursor over different choices if there are multiple options. See Windows® manuals for Windows operation via keyboard.
Þ+Ù
When you have more than one application Window open, use Þ+Ù to switch between tasks.
Dialog Box Dialog boxes receive commands or information; for example, a file name dialog box receives information about a file name. Accepts the information you have selected or typed. Stops the operation, ignoring your choices.
Description of Reporting Units Unless otherwise stated, all parameter units are shown in the US unit format (cells/µL) throughout the manuals.
GRAPHICS All graphics, including screens and printouts, are for illustration purposes only and must not be used for any other purpose.
COMPUTER PROGRAM STATEMENT WARNING This computer program is protected by international copyright laws, and unauthorized copying, use, distribution, transfer, or sale is a violation of those laws that may result in civil or criminal penalties. This computer program may also be subject to additional restrictions contained in a license granted by Beckman Coulter, Inc. to the authorized user of this computer program or to the authorized owner or other authorized user of the system onto which this computer program is installed. Any violation of the license provisions may result in additional civil penalties, including an injunction and damages. Please refer to the computer program or system agreement or to the computer program or system documentation for the terms and conditions of that license.
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INTRODUCTION COMPUTER PROGRAM STATEMENT
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1INSTALLATION 1 1.1
INSTALLING MICROSOFT EXCEL SOFTWARE Install the Excel software before installing the MXP software, version 2.2. During the MXP software installation, an Add-In is automatically installed into your Excel software. Follow the manufacturer’s instructions to install the Excel software (version 2002 or version 2003 only) on your FC 500 MPL computer. Ensure the Excel security level is NOT set to High (Tools tt Macro tt Security). Restart the computer after installing the Excel software. Register your copy with Microsoft when you install it.
1.2
INSTALLING MXP SOFTWARE Contact your Local Beckman Coulter representative to install MXP software, SQL Server software or Beckman Coulter Accounts and Permissions software. You can use the instructions below to, r
install the 21 CFR Part 11 Option software or
r
set the CD-ROM drive to Autorun.
Preinstallation Checks Before starting the installation procedure, check: r
Your system operating system is Windows® 2000 or Windows XP.
r
You are logged into Windows as an administrator.
r
Microsoft Excel software (version 2002 or 2003) is installed and the security level is NOT set to High.
Installing The 21 CFR Part 11 Option Disk Use this procedure if you currently have the standard MXP software, version 2.2 with SQL Server 2000 (without the CFR 21 Part 11 option), installed on your system, and you are now upgrading your system with the 21 CFR Part 11 option. If you have MXP v2.2 with SQL Server 2005 Express, contact your local Beckman Coulter Representative for installation. The 21 CFR Part 11 option requires a different Romlock than the Romlock required for the standard MXP software, version 2.2, installed on your system before performing this installation procedure. DaCS software is automatically installed on your system as part of the MXP software - 21 CFR Part 11 option installation. DaCS software is a 21 CFR Part 11 compliance tool for MS Excel files generated from exporting data from the MXP software. Once the 21 CFR Part 11 option of the MXP software is installed on your system, you cannot uninstall the MXP software. Note: Always close all other applications before starting the install procedure.
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1-1
INSTALLATION INSTALLING MXP SOFTWARE
To install the 21 CFR Part 11 Option disk:
1
Insert the CD-ROM labeled 21 CFR Part 11 Option into the CD-ROM drive. The 21 CFR Part 11 Option CD-ROM should Autorun the MXP Software 21 CFR Part 11 Option installation and these screens appear. Note: If the 21 CFR Part 11 Option CD-ROM does not Autorun click here for additional instructions.
2
The 21 CFR Part 11 Option Welcome screen appears. to continue.
1-2
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INSTALLATION INSTALLING MXP SOFTWARE
3
Read the Beckman Coulter License Agreement and
to accept the License Agreement and proceed with the installation.
4
The Important Information screen contains important information about Windows®, Romlock, Cytometer Control Files and other miscellaneous information. Scroll to down to view all the information and continue.
5
to
Review the setup information. If an error is identified, click as necessary to locate the dialog where the problem can be fixed. Once you are satisfied that everything is correct, files onto the hard disk.
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to copy the
1-3
1
INSTALLATION INSTALLING MXP SOFTWARE
6
Remove the 21 CFR Part 11 Option Disk from the drive. Note: Store this disk securely.
7
to restart the computer now.
1-4
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INSTALLATION INSTALLING MXP SOFTWARE
If the CD-ROM Does Not Autorun If the CD-ROM does not Autorun,
1
2
.
Use the Look In drop down window to locate the MXP Software CD-ROM. This is usually drive D on most systems but it may be another drive (E, F, and so on). .
3
4
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.
Return to the beginning of the install procedure for the disk you were installing.
1-5
1
INSTALLATION INSTALLING MXP SOFTWARE
1-6
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2ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION 2 2.1
OVERVIEW The System Administrator’s Guide should be kept in a secure location so only the System Administrator has access to it. This Chapter is intended for System Administrators that have MXP software version 2.2 with the 21 CFR Part 11 option installed on their FC 500 MPL.
MXP Software System Administrator Guide Availability Online You can access this System Administrator’s Guide when you are online ONLY if you are logged into the MXP software Administrator screens. Press any of the HELP buttons located on the Administrator-only accessible screens and you are linked to the System Administrator’s Guide. PDF Files Use a PDF file if you want to print the manual. A PDF file of the System Administrator’s Guide (628899xx.pdf) is provided in the hidden Windows directory: C:\MXP\ADHP. 21 CFR Part 11 Regulation
To view hidden files in Microsoft Windows: r
Open Windows Explorer.
r
Tools tt Folder Options.
r
the View tab.
r
Show hidden files and folders.
The FDA’s Electronic Records and Electronic Signatures Rule (21 CFR Part 11) outlines the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. It defines the standards by which an organization can use electronic records to meet its record-keeping requirements.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION OVERVIEW
MXP Software with 21 CFR Part 11 Option Implementation and compliance of 21 CFR Part 11 is the responsibility of the laboratory creating and signing the electronic records. Proper laboratory procedures and key features of the MXP software with the 21 CFR Part 11 option can be used to achieve compliance with this regulation. The FC 500 MPL with MXP software is a closed system per the definition stated in Section 11.3, Subpart A of the regulation: Closed System - environment in which system access is controlled by persons responsible for the content of electronic records on the system. All FC 500 MPL users in your laboratory must be trained to properly and consistently use your laboratory’s procedures regarding electronic records and signatures. Passwords Passwords and user access to the MXP software must be controlled. The 21 CFR Part 11 option provides the tools to the System Administrator to keep the user passwords in compliance. Your laboratory can have more than one person with System Administrator status to ensure that System Administrator functions can be performed when needed for your laboratory’s workflow. The System Administrator can: r
Change the Administrator default Password immediately and keep the new password in a secure location.
r
Enter the original Password for each User ID after installation of MXP 2.2. See Change This User’s Password for details.
r
Set the Password Timeout interval when a user’s password expires and must be changed.
r
Select the time interval when Auto-Logout Timeout occurs due to user inactivity.
r
Set the Password Failure Attempts limit.
r
Unlock the User ID and reset the password when a user exceeds the Password Failure Attempts limit and is locked out of the software.
r
Gain access to loaded MXP software as an Administrator using the File tt Log In feature, only if: t
The MXP software was locked by a user using the 21 CFR 11 tt Lock Software feature, or
t
A user was locked out of an active session of the MXP software due to exceeding the password failure attempts limit or
t
An automatic logout timeout occurred when the time limit was reached for user inactivity at the mouse or keyboard during an active session of the MXP software. Note: The User ID that was logged in before the lockout occurred is listed as the User ID for any activity the System Administrator performs while in MXP software. To ensure accurate Audit Trail information, the System Administrator should log out as soon as possible after performing any needed actions in MXP software.
2-2
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION OVERVIEW
Audit Trails Only the System Administrator can view and print the Audit Trails in the MXP software. Audit Trails can display Login/Logout, file handling, automated, and administrative activities for specified dates and users. See VIEWING AND PRINTING AUDIT TRAILS for detailed instructions. Electronic Signatures MXP provides each user with the ability to sign versions of protocol, histogram, listmode, panel and PDF files. See the Reference manual for details. Only the System Administrator can add, delete or modify default Save Comments. A user can select one of these default comments or enter their own comment when saving a new version of a listmode, histogram, protocol, panel, or PDF file. See CHANGING DEFAULT SAVE COMMENTS for details. Archiving Only the System Administrator can archive and restore data files. See: ARCHIVING DATA RESTORING ARCHIVED DATA RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE
DaCS Software DaCS software is included with the 21 CFR Part 11 option of MXP software, version 2.2. This software provides electronic signature capabilities and audit trails for Microsoft Excel worksheets. Note: To avoid unnecessary DaCS errors when launching the MXP software and to allow access to all file/folders necessary for 21 CFR Part 11 read/write functionality, set up Windows User accounts with full Administrator rights on a FC 500 MPL flow cytometer that has a Workstation with MXP 21 CFR Part 11 software installed. DaCS Administrator Manual Click here to access the DaCS Administrator manual, if you are reading this while you are online on the FC 500 MPL. Use a PDF file if you want to print the manual. A PDF file of the DaCS Administrator manual (Administrator Manual.PDF) is provided:
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r
In the hidden Windows directory: C:\MXP\ADHP. See above how to view hidden directories in Windows.
r
On the Cytomics FC 500 MPL System Administrator’s Guide CD-ROM.
2-3
2
ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION MULTI-USER SIGN ON
2.2
MULTI-USER SIGN ON Plate Display When you open the MXP software, the Plate Display appears with a default undefined 96 well plate configuration before the Startup Wizard appears. Once a user logs on at the Startup Wizard screen, the Plate Display window shows the last plate configuration defined by that user. Note: When anyone logs into the MXP software with a new User ID, Not a valid worklist file appears. Until a valid worklist is saved for that User ID, this message appears after log in.
Startup Wizard After the default Plate Display appears, the Startup Wizard screen appears allowing Password entry and access to the system. User ID Logged In Log Into and Log Out of DaCS Software Password Admin Button Help Button Finish Button
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION MULTI-USER SIGN ON
On the initial Startup after installation, only the Administrator User ID is available. All Users (including any that were migrated from version 1.0 or 1.1 during installation) must be set up by the System Administrator to have access to the MXP software. After the User IDs are set up by the System Administrator, the Startup Wizard screen displays the User IDs of all those who have access rights to MXP software and whether or not they are logged in to the system. The default System Administrator Password is “password”. It is vital that the System Administrator Password is changed as soon as possible by using the Modify User option within the User Administration screen. See USER PROFILE – USER ID for details. If you forget your Administrator password after you have changed it, call your Beckman Coulter representative to reset it. To sign on and access the administration tools, highlight the Administrator User ID and enter the Password. The Admin button is then available. Select this button to access the User Administration Screen dialog box. The User ID “Administrator” and are for the System Administrator’s use only. You cannot log into MXP software with the Administrator User ID, except to log in after a user has manually locked the software or the user exceeded the password failure attempts limit. However, the User ID that was logged in before the lockout occurred is listed as the User ID for any activity the System Administrator performs while in MXP software. To ensure accurate Audit Trail information, the System Administrator should log out as soon as possible after performing any needed actions in MXP software. Note: If a red X appears next to your User ID ( r
r
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) check the following.
Ensure the pathway for the user directory with the red X is: t
not a network drive if the network connection is not met.
t
not a Zip drive.
t
not a CD-ROM drive.
Ensure all of the user folders are intact for the user ID with the red X. If any of the following folders are missing from that user’s directory, use Windows Explorer to create the missing folders. t
AcquisitionProtocol
t
AnalysisProtocol
t
HST
t
HTML
t
Images
t
LMD
t
Panel
t
PDF
t
Results
t
Worklist
2-5
2
ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION MULTI-USER SIGN ON
r
Access the User Administration dialog box. t
Select Restore Archive.
t
Close the Select Archive for Restoration dialog box without performing any actions.
t
Log out of the MXP software completely.
User ID This lists all the User IDs that are allowed access to the system. User IDs are a minimum of 3 characters and a maximum of 24 characters. See also: heading User ID in the User Profile User ID section. Note: The DaCS software requires a minimum of 4 characters to name a User. Use a minimum of 4 characters in your MXP User ID if you intend to create Users in DaCS software. Logged In Indicates whether or not the Users are logged in. Log Into and Log Out of DaCS Software When you log into MXP software, no additional actions are needed to be automatically logged into the DaCS software when data is exported to MS Excel. When you are logged into MXP software, the MXP software User IDs are used for the DaCS software. When you log out of MXP software, you are automatically logged out of the DaCS software. Password This is where the user’s password is entered. Passwords must be a minimum of 6 characters and a maximum of 24 characters. Blanks are not allowed. For best security create a password with at least eight characters, including letters, numbers (0-9) and/or symbols. The default Administrator Password is “password”. If you forget your Administrator password after you have changed it, call your Beckman Coulter representative to reset it. Admin Button Allows access to the User Administration Tools, which allow the addition, removal and modification of User profiles and Workgroups, the creation of Export Billing Logs, the changing of default Save comments, the archiving of data, the restoring of archived files, the viewing of Audit Trails, the setting of time criteria for auto logouts and password changes, the setting of password failure attempts and the entering of the Cytometer serial number. Finish Button Allows access to the MXP software after a user has entered a correct password. Help Button Allows access to the online help for all non System Administrator MXP software screens.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION SIGN-ON ADMINISTRATION
2.3
SIGN-ON ADMINISTRATION User Administration Screen This screen allows the System Administrator to: add, delete and modify Users and their user profiles including passwords, create user Workgroups, create Export Billing Logs, view and print Audit Trails, change default save comments, archive files, restore archived data files, recover files from restored *.archive files, set up time criteria for automatic logouts and password expiration, set the limit for password failure attempts and enter the Cytometer serial number. Add User Delete User Modify User Workgroups Export Log View Audit Trail Change Default Save Comments Archive Data Restore Archive Recover File from Archive Auto-Logout Timeout Password Timeout Password Failure Attempts Cytometer Serial Number
Add User Use this button to add a new user. See USER PROFILE – USER ID. Delete User Highlight the User ID you wish to delete from the system and
.
A confirmation dialog box is displayed. Choose Yes to delete the user or No to revert to the User Access Control dialog box. Note: The User ID no longer appears but for audit purposes the User ID and related information remain available in the BCA&P database. Modify User Use this button to modify an existing user. See USER PROFILE – USER ID. PN 628899BB
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION SIGN-ON ADMINISTRATION
Workgroups Use this button to set up workgroups and assign users to the workgroups. See SETTING UP WORKGROUPS. Export Log Use this button to set up a billing log showing the date and time each user is logged onto MXP software. See EXPORT BILLING INFORMATION. View Audit Trail Use this button to define the Audit Trails you want to view and print by date, user, and activity type. See VIEWING AND PRINTING AUDIT TRAILS for detailed instructions how to view and print Audit Trails. Change Default Save Comments Use this button to add, modify or remove System Administrator-defined Save comments. A Save comment describes the reason for a version change to a file. The System Administrator-defined Save comments do not affect the predefined Save comments provided by MXP software. See CHANGING DEFAULT SAVE COMMENTS for a list of the predefined Save comments and detailed instructions how to change default Save comments. Archive Data Use this button to define the archive location and the search criteria to archive listmode, histogram, worklist, protocol, and PDF files into the Beckman Coulter Accounts and Permission (BCA&P) database. These files will be available for retrieval at a later time. See ARCHIVING DATA for detailed instructions. Restore Archive Use this button to retrieve all of the files from one or more *.archive file. See RESTORING ARCHIVED DATA for detailed instructions. Recover File from Archive Use this button to retrieve one of the files from a restored *.archive file. See RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE for detailed instructions. Auto-Logout Timeout Set the number of minutes (5 - 30) of inactivity by the user that causes the user to be automatically logged out of the system. Inactivity means no mouse or keyboard actions were made by the user. The Startup Wizard screen appears after an automatic logout unless an automated activity is in progress. If an automated timeout lockout occurs during any automated activity (Acquisition, Listmode playback, Batch AutoMATOR, or AutoSetup) the system does not completely log out of the software, it locks the software except for the File tt Log In feature. The user or the System Administrator can log back into the system after this type of automatic log out with the File tt Log In feature.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION SETTING UP WORKGROUPS
Password Timeout Set the number of days (7 - 100) to define the time period when a user must change the password. Users are notified by the system when the time limit has been reached and are prompted to change the password before logging in. Password Failure Attempts Set the number of incorrect password attempts (2 - 5) that causes the user to be locked out of the MXP software. When a user is locked out due to failed password attempts, the System Administrator must unlock the user and enter a new password before the user can log back into the MXP software. Cytometer Serial Number Enter the serial number of the Cytometer (9-10 characters) connected to the Workstation.
2.4
SETTING UP WORKGROUPS Selecting the Workgroup option allows the System Administrator to set up various Workgroups of your choice depending upon your requirements. Members of a Workgroup are allowed to easily share their directories on the Resource Explorer. Choose any names to suit your requirements and then enable the checkbox next to the names of users you wish to add to the Workgroup. Workgroup Selection Users Edit Button Within the display, ALL Users assigned to the system are shown BUT only those within the particular Workgroup shown in the Workgroup Selection box have the checkbox beside the User ID enabled.
See also: User Administration Screen Workgroup Selection Displays the current Workgroup. Select the drop down list box to display and select other Workgroups.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION SETTING UP WORKGROUPS
Users Lists ALL the Users assigned to the system. Those with the checkbox activated by their User IDs are members of the particular Workgroup shown in the Workgroup Selection box. Users can be assigned to multiple Workgroups. To add a user to the Workgroup, click to enable the checkbox. To remove a user from the Workgroup, click to disable the checkbox. Edit Button Allows access to the Edit Workgroups screen. Edit Workgroups This screen is used to Add or Delete specific Workgroup names. Add Delete
Add to add a new Workgroup to the system. Type the new Workgroup name in the Text Edit box and
.
Delete Highlight the appropriate Workgroup from the list displayed and to delete a particular Workgroup from the system. To edit the name of a particular Workgroup, first delete the Workgroup and then add it as a “new” Workgroup. See also: Workgroups User Administration Screen
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION EXPORT BILLING INFORMATION
2.5
EXPORT BILLING INFORMATION Selecting the export billing option allows a text file log to be created showing the date and time each User has spent logged on to MXP software.
1
.
2
Enter the date range for the log and .
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION EXPORT BILLING INFORMATION
3
Select the users to include in the log and
4
.
Choose to direct the information to the Clipboard or to a File. If File is selected, you can either enter a valid File Name in the box or use the Browse Button to select an appropriate file. Select between Tab delimited (MS Excel default) or a Comma delimited text format file.
5
to end.
See also: User Administration Screen
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION VIEWING AND PRINTING AUDIT TRAILS
2.6
VIEWING AND PRINTING AUDIT TRAILS An Audit Trail can display the date and time, User ID, activity type and any Save comment based on the criteria specified by the System Administrator. The System Administrator can view and print specific Audit Trails by selecting the date, user and activity type criteria needed. See Table 2.1 for a list of the activities included with each Activity Type selection. The MXP software considers the time period from when the System Administrator logs into Close on the User the Startup Wizard screen until the System Administrator Administration dialog box to be one work session. During a work session when you exit the Audit Trail screen and then return to the Audit Trail screen, all previous selections are still displayed. When you exit the Administrator screens and end the work session the Audit Trail fields are reset to the default selections. Table 2.1 Audit Trail Activity Types Activity Type Selection
Activities Displayed
Log In/Log Out
User log in, user log out, Administrator log in, Administrator log out, automatic log out, password change, user log in failure attempt.
File Handling
Saving a file, loading a file, signing a file.
Automated Activities
Start of an automated activity and end of an automated activity. Automated Activities are: acquisition, listmode playback, batch AutoMATOR, AutoSetup.
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Admin Activities
Archive creation, viewing audit trails, Administrator log in, Administrator log out, password change (Administrator only), Administrator log in failure attempt.
All Activities
All Activities displays all of the activities described for all of the other Activity Type selections.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION VIEWING AND PRINTING AUDIT TRAILS
Procedure If you intend to print an Audit Trail, be aware that the data processing time required may take several minutes or longer depending on the amount of data specified by the audit criteria you select. To minimize data processing time, check that you have narrowed your criteria selections to request only the information you really need before requesting a printout. If you need to print Audit Trails that contain a large amount of data, schedule the printing during an appropriate time of the work day. To view and print Audit Trails:
1
2
View Audit Trail.
Change the criteria selections as described below to define the Audit Trail needed. An updated Audit Trail appears after each change made. Note: The first time you enter the Audit Trail screen during a work session, it displays all of the activity types for all users that occurred in the last seven days.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION VIEWING AND PRINTING AUDIT TRAILS
3
Select a Start Date and an End Date to define your time criteria: r
the Start Date drop down list.
r
the arrow buttons to display a different month/year. t
displays the previous month. displays the previous
t year.
4
t
displays the next month.
t
displays the next year.
r
on the date to select it. The date then appears in the Start Date field.
r
Repeat for the End Date.
Select a User from the Filter by User drop down list. Note: All Users includes all current users and all deleted users.
5
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Select an activity from the Filter by Activity Type drop down list. See Table 2.1 for a description of which activities appear for each Activity Type selection. r
If you selected File Handling, additional File Type Selection fields appear so you can select specific files. Proceed to step 6.
r
If you did not select File Handling, proceed to step 7.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION VIEWING AND PRINTING AUDIT TRAILS
6
If you selected File Handling as the Activity Type, complete these File Type Selection fields to define the file/files for the Audit Trail: r
Select a file type from the Filter by File Type drop down list.
r
Select All Files from the Filter by File drop down list, or to display a Select File dialog box where you can select a single file of the selected file type.
.
Note: If you select a single file, it then appears in the Filter by File drop down list while you remain in this Administrator work session.
7
Print at any time to print out the currently displayed Audit Trail.
Note: Be aware that the print time required may take several minutes or longer depending on the amount of data specified by the audit criteria you selected.
8
to end this session and exit this screen. Note: If you re-enter the Audit Trail screen, the same criteria appears as long as you are in the same System Administrator work session.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION CHANGING DEFAULT SAVE COMMENTS
2.7
CHANGING DEFAULT SAVE COMMENTS The MXP software provides these Save comments that cannot be removed or modified: r
Adjusted/added regions/gates
r
Updated comp values
r
Added plots
r
Printed PDFs
r
Added stats displayed
r
Exported data
r
Updated FlowPAGEs
If your laboratory requires additional Save comments, this feature allows you to add, modify or remove System Administrator-defined Save comments. System Administrator-defined Save comments are available to the user in a pull down menu in addition to the MXP provided Save comments. The Save comments provided by MXP software along with all System Administrator-defined Save comments appear to the user on this list. Before a user can save a version of a listmode, histogram, protocol, panel, or PDF file, a Save comment must be selected from a pull down menu of all the Save comments in the system or manually entered by the user. The Save comment describes the reason for the version change to the file.
Procedure To add, modify or remove a System Administrator-defined Save comment:
1
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Change Default Save Comments.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION CHANGING DEFAULT SAVE COMMENTS
2
This dialog box displays only the Save comments created by the System Administrator. r
Highlight a comment and Remove to delete the comment from the list,
OR r
Add or Modify to add or edit a comment.
If you selected Add or Modify, the Edit Comment dialog box appears. Type in the new or modified comment and
3
2-18
.
to save the changes you made and exit this dialog box.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
2.8
ARCHIVING DATA Use this feature to archive listmode, histogram, worklist, protocol, panel and PDF files located in the Beckman Coulter Accounts and Permission (BCA&P) database. These files are available for retrieval at a later time. Be sure to document the *.archive file name and the files it contains for easy retrieval at a later date. Archive data on a regular basis. When your BCA&P database size nears 2 GB, users logging into the MXP software are asked to notify the System Administrator to perform an archive. Once the database size reaches 4 GB, users are not allowed to log into the MXP software until the System Administrator performs an archive. Archive Location Archive Criteria Archive By Date Archive Histogram, Panel, Protocol or PDF Files Archive LMD Files By
Archive Location Select the path to the archive location, including the drive and the name for the *.archive file. The extension “.archive” designates a group of archived files.
Archive Criteria Enter the criteria as needed in these fields to specify exactly the files you want to archive to a specific *.archive file. Precautions IMPORTANT Do not interrupt the archiving process. Interruptions during the archiving process could result in lost data. Wait until the progress bar shows that the archiving process is completed before requesting any other software functions.
Do not interrupt the MXP archiving process until the progress bar shows the process is 100% completed. Establish a system to provide a unique, meaningful descriptive name for each *.archive file in order to allow easy retrieval at a later time when you need to restore archived files. PN 628899BB
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
Archive to a location that has sufficient space to hold all of the archived files. It is not recommended to archive to removable media. Follow your laboratory’s record handling procedure for archiving. Do not archive protocol and panel files that will need to be used in a Worklist with non-archived panels. This causes a conflict in the system and generates related error messages. Note: *tdf files are not archived. Archive By Date Archive By Date if you want to limit the files to be archived to a specific time frame in
addition to the other file type search criteria defined on this screen. The search date used by the system is the date of version one of the file. r
Select On or Before and select a date to archive all defined files up to that date that also fit the other criteria defined on this screen.
r
Select Between and a start date and an end date to archive all defined files between those two dates that also fit the other criteria defined on this screen.
Do not select this feature if you do not want to specify a time frame. Archive Histogram, Panel, Protocol or PDF Files Select one or more of these types of files to archive: histogram, worklist, protocol, panel, and PDF files. In the Where Filename matches phrase... field for each selected file type, enter a string of characters that are contained in all of the file names that you want to archive. The system searches all current (non-archived) files in the BCA&P database for all file names of the file type selected that contain this string of characters and archives these files. The string of characters can be the file extension (.hst, .wkl, .pro, .pdf) or some other identifying part of the file name.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
Archive LMD Files By Select one or more of these FCS keywords as the search criteria for the listmode files to be archived: r
Protocol name
r
Sample ID 2
r
Panel name
r
Sample ID 3
r
Worklist (*.tdf) name
r
Sample ID 4
r
Experiment (from the Workspace Preferences User Info Tab)
r
Acquisition date/time (Use the FCS Keyword format for the date DD-MM-YY).
r
Sample ID 1
r
User ID
In the Where FCS Keyword matches phrase... field next to a selected type of FCS keyword, enter a string of characters that you want the FCS keyword to contain. The system searches for all listmode files that contain that type of FCS keyword with that string of characters and these are the files that are archived.
Procedure To archive data files:
1
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Archive Data.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
2
Select only the archive criteria on this screen needed to define the files you want to be archived: r
Location where to send the archived files, and
r
Date range, and/or
r
File types to be archived, and/or
r
Phrases that you want each FCS keyword of the histogram, panel, protocol, PDF, or LMD file to contain.
IMPORTANT Do not use a previously used name for an *.archive file. This will cause the new *.archive file to overwrite the old *.archive file with the same name. Always use a unique *.archive file name.
3
Use the Browse Button to select an appropriate Archive Location. The *.archive file needs to follow the naming convention *.archive.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
4
Archive By Date if you want to specify a time frame for the files to be archived. The search date used by the system is the date of version one of the file.
r
Select On or Before and select a date, or
r
Select Between and select a start and an end date.
Note: To select a date:
5
r
Access the calendar from the drop down list.
r
Use the arrow buttons to change the desired month and year.
r
on the date to select it.
for each file type (histogram, panel, protocol, PDF) that you want to archive. If you want to narrow the files to be archived: r
PN 628899BB
Type in a string of characters in the Where Filename matches phrase... field next to each selected file type to archive only files containing that string of characters.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION ARCHIVING DATA
6
Archive LMD Files By if you want
to archive listmode files: r
for each type of FCS keyword you want the archived listmode file to contain.
r
If you want to narrow the listmode files to be archived: t
7
Type in a string of characters in the Where FCS Keyword matches phrase... field next to each selected FCS keyword. Only LMD files with these selected FCS keywords containing the defined string of characters will be archived.
Archive to archive the selected files to the defined archive location listed on this screen.
IMPORTANT Do not interrupt the archiving process. Interruptions during the archiving process could result in lost data. Wait until the progress bar shows that the archiving process is completed before requesting any other software functions.
8
While the progress bar appears, do not interrupt this process or try to exit this screen. Wait until the progress bar shows the archive process is 100% completed before you continue.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION RESTORING ARCHIVED DATA
2.9
RESTORING ARCHIVED DATA Use this feature to restore the listmode, histogram, worklist, protocol, panel and/or PDF files from an *.archive location. IMPORTANT Do not interrupt the restore process. Interruptions during the restore process could result in lost data. Wait until the progress bar shows that the restore process is completed before requesting any other software functions.
Do not interrupt the MXP restore process until the progress bar shows the process is 100% completed. This procedure restores the selected *.archive file. However, individual files need to be selected to be restored for further analysis from the *.archive file into MXP software with the RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE procedure. Note: To find the *.archive file location of the archived file you want to restore, try to open the archived file in a Open File dialog box in the MXP software, with the Show Archived Files box selected. If the archived file has not been restored, a message appears displaying the *.archive file name and the directory path where the archived file is located.
1
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Restore Archive.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION RESTORING ARCHIVED DATA
2
3
Select the *.archive file to be restored: a.
the desired directory in the Look in: list box.
b.
the type of file (*.archive) in the Files of type: list box.
c.
the name of the *.archive file you want to restore.
.
IMPORTANT Do not interrupt the restore process or try to exit this screen. Interruptions during the restore process could result in lost data. Wait until the progress bar shows that the process is completed before requesting any other software functions.
4
While the progress bar appears, do not interrupt this process or try to exit this screen. Wait until the progress bar shows the restore process is 100% completed before you continue.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE
2.10 RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE You can only recover an individual archived file after you have performed the RESTORING ARCHIVED DATA procedure for the *.archive file where it is located. After the *.archive file is restored, any individual file that requires further analysis needs to be recovered. After the individual archived file is recovered, it is available in the MXP software in the designated location and is considered a new record for 21 CFR Part 11 purposes.
Procedure Perform this procedure to recover a file from an *.archive file that you have already restored.
1
2
Recover File From Archive.
Select the desired restored file: a.
Use the Browse Button to select the Restore Location. This is the location where you want the selected files to be restored. The default is the location where the file was originally saved.
b.
the desired directory in the Look in: list box to search for the
file. c.
PN 628899BB
if you want to display all of the versions of the selected file.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION RECOVER A FILE FROM A RESTORED *.ARCHIVE FILE
3
If the Checked In Versions section is displayed: r
Show Only Signed Files to
only display signed files. r
the Signed field of a version to see detailed signature information.
r
to hide the Checked In Versions displayed.
Note: The signature information is not restored with the restored archive file.
4
Restore to restore the selected version of an archived file. If you did not select a
specific version of a file, then MXP restores the most recent version. Electronic signatures saved with the archived file are not retained with the restored archived file. Note: For 21 CFR Part 11 purposes, the restored archived file is considered a new record and changes to version one before you can work with it.
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r
If the default restoration location was selected, the file is automatically checked into the active BCA&P database as version one.
r
If you selected an alternate restoration location, the file is automatically checked into the active BCA&P database as version one when the user loads the file into MXP.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION USER PROFILE – USER ID
2.11 USER PROFILE – USER ID r
When a new user is added with the Add user button, or an existing one requires their details changed with the Modify user button, the following screen is displayed.
r
If you are modifying a user or changing the Administrator Password, the User ID/First Name/Last Name are grayed out.
r
If you migrated users from version 1.0 or 1.1 of the MXP software, the User ID data you entered appears here.
User ID First Name Last Name Title/Description Training Info User Trained? Date Trained By Whom Privileges Access other files? Remember last accessed LMD directory? Overwrite acquired data files? Overwrite other data files? Add Absolute Calibration Batches Can Modify Custom Dyes? Status Change This User’s Password Print User Information
See also: USER PROFILE – PATHS User Administration Screen
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION USER PROFILE – USER ID
User ID Enter a unique User ID for a new user. Previously used User IDs for deleted users cannot be reused. Existing User IDs cannot be modified. The Administrator name cannot be modified or deleted. User IDs are a minimum of 3 characters and a maximum of 24 characters. Note: The DaCS software requires a minimum of 4 characters to name a User. Use a minimum of 4 characters in your MXP User ID if you intend to create Users in DaCS software.
First Name Enter the first name of the person for this User ID. Once entered, the first name cannot be modified or deleted.
Last Name Enter the last name of the person for this User ID. Once entered, the last name cannot be modified or deleted.
Title/Description Enter the user’s title or job description. This field can be changed as needed.
Training Info The System Administrator can document the training that each user received.
User Trained? if the user has been trained.
Date Trained Enter the date when the user was trained.
By Whom Enter who trained the user.
Privileges The System Administrator can assign the available privileges.
Access other files? This feature is not available with the 21 CFR Part 11 option.
Remember last accessed LMD directory? This feature is not available with the 21 CFR Part 11 option.
Overwrite acquired data files? This feature is not available with the 21 CFR Part 11 option.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION USER PROFILE – USER ID
Overwrite other data files? This feature is not available with the 21 CFR Part 11 option.
Add Absolute Calibration Batches to allow this user to enter and modify information available in the Analysis tt Absolute Count Calibration dialog box.
Can Modify Custom Dyes? This feature is not available with the MXP software.
Status Displays the current status of this User ID: Locked or Unlocked. r
r
Locked means this user cannot log into the MXP software. A User is locked: t
Until the System Administrator unlocks the User after setting up the User ID information for the first time.
t
Whenever the user reaches the defined number of unsuccessful password attempts allowed.
Unlocked means this user can log into the MXP software and access all of the privileges defined.
Change This User’s Password This feature allows you to assign a password: r
For the user’s initial log in to the system after installation,
r
Whenever a user forgets the current password, or
r
Whenever a user reaches the defined number of unsuccessful password attempts allowed.
The System Administrator cannot view user-created passwords.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION USER PROFILE – USER ID
To change a user password:
1
2
Change Password.
Enter the new password in the Enter New Password field. Re-enter the new password in the Re-enter New Password field. Note: See Password for Password criteria.
3
OK.
Note: When a user enters this new password for the first time after the System Administrator changed the password, the system prompts the user to change their password immediately before logging into the MXP software.
Print User Information Print to print out the displayed information for this User ID. For your records, you can have the user verify the printed information and then sign the printout.
See also: User Administration Screen
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION USER PROFILE – PATHS
2.12 USER PROFILE – PATHS This screen displays the User directory Paths for the local copies of the current version of the file from the BCA&P database for different file types. A local copy of the Listmode files are stored in subdirectories titled with the Worklist Name, Date and Time under the LMD directory. Browsing Button Home Path Details Backup
See also: USER PROFILE – USER ID User Administration Screen Browsing Button The Browse Button
is not available with the 21 CFR Part 11 option.
Home Shows the Home Directory Path that applies to that User. Path Details Shows the paths to the destination directories for the different File types within MXP software. Backup This feature is not available with the 21 CFR Part 11 option.
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ADMINISTRATOR’S TOOLS - WITH 21 CFR PART 11 OPTION DaCS SOFTWARE
2.13 DaCS SOFTWARE Setting Up User IDs MXP Software User IDs r The MXP software System Administrator sets up the User IDs and passwords for MXP software. r
When you are logged into the MXP software and data is exported to MS Excel, you are automatically logged into the DaCS software.
r
Your MXP User ID appears at the top of the Excel screen.
DaCS Users For Use Outside MXP Software The System Administrator must set up Users in the DaCS software for them to have access to additional functionality, such as electronic signatures, during analysis of Excel data files when MXP software is not open. Note: The DaCS software requires a minimum of 4 characters to name a User. Use a minimum of 4 characters in your MXP User ID if you intend to create Users in DaCS software. To set up Users in the DaCS software:
1
2
3
Double click C:\Program Files\Wimmer Systems\MXP DaCS Interface Workbook.xls.
Start DaCS on the DaCS software screen that appears.
Follow the instructions in the DaCS Administrator manual, which is called Administrator manual.PDF and is located in the hidden directory C:\MXP\ADHP, to set up a User in the DaCS software for each User ID in the MXP software. See MXP Software System Administrator Guide Availability for instructions how to view hidden directories in Windows.
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3ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE 3 3.1
OVERVIEW The System Administrator’s Guide (CD-ROM and any printed copy) should be kept in a secure location so only the System Administrator has access to it. This Chapter is intended for System Administrators that have the Standard MXP software version 2.2 (without the 21 CFR Part 11 option) installed on their FC 500 MPL. Only the System Administrator can access the MXP software User Administration Screen to set up user related information.
MXP Software System Administrator Guide Availability Online You can access this System Administrator’s Guide when you are online ONLY if you are logged into the MXP software Administrator screens. Press any of the HELP buttons located on the Administrator-only accessible screens and you are linked to the System Administrator’s Guide. PDF Files Use a PDF file if you want to print the manual. A PDF file of the System Administrator’s Guide (628899xx.PDF) is provided: r
In the hidden Windows directory: C:\MXP\ADHP.
r
On the Cytomics FC 500 MPL System Administrator’s Guide CD-ROM.
To view hidden files in Microsoft Windows: r
PN 628899BB
Open Windows Explorer.
r
Tools tt Folder Options.
r
the View tab.
r
Show hidden files and folders.
3-1
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE MULTI-USER SIGN ON
3.2
MULTI-USER SIGN ON Plate Display When you open the MXP software, the Plate Display appears with a default undefined 96 well plate configuration. Once a user logs on at the Startup Wizard screen, the Plate Display window shows the last plate configuration defined by that user. Note: When anyone logs into the MXP software with a new User ID, Not a valid worklist file appears. Until a valid worklist is saved for that User ID, this message appears after log in.
Startup Wizard After the default Plate Display appears, the Startup Wizard screen appears allowing Password entry and access to the system. User ID Logged In Password Admin Button Finish Button Help Button
On the initial Startup after installation, only the Administrator User ID is available. All Users (including any that were migrated from version 1.0 or 1.1 during installation) must be set up by the System Administrator to have access to the MXP software. After the User IDs are set up by the System Administrator, the Startup Wizard screen displays the User IDs of all those who have access rights to MXP software and whether or not they are logged in to the system. 3-2
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE MULTI-USER SIGN ON
The default System Administrator Password is “password”. It is vital that the System Administrator Password is changed as soon as possible by using the Modify User option within the User Administration screen. See USER PROFILE – USER ID for details. If you forget your Administrator password after you have changed it, call your Beckman Coulter representative to reset it. To sign on and access the administration tools, highlight the Administrator User ID and enter the Password. The Admin button is then available. Select this button to access the User Administration Screen to add, remove and modify User profiles, including passwords, as well as the creation of user Workgroups plus the creation of Export Billing Logs, setting up time criteria for user change of password, setting the limit of password failure attempts and the entering of the Cytometer serial number. The User ID “Administrator” and are for the System Administrator’s use only. You cannot log in to MXP software with the Administrator User ID. Note: If a red X appears next to your User ID ( r
r
) check the following.
Ensure the pathway for your user directory is: t
not a network drive if the network connection is not met.
t
not a Zip drive.
t
not a CD-ROM drive.
Ensure all of your user folders are intact. If any of the following folders are missing from your user directory, use Windows Explorer to create the missing folders. t
AcquisitionProtocol
t
AnalysisProtocol
t
HST
t
HTML
t
Images
t
LMD
t
Panel
t
PDF
t
Results
t
Worklist
User ID This lists all the User IDs that are allowed access to the system. User IDs are a minimum of 3 characters and a maximum of 24 characters. See also: heading User ID in the User Profile User ID section. Logged In Indicates whether or not the Users are logged in.
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE MULTI-USER SIGN ON
Password This is where the user’s password is entered. Passwords are a minimum of 6 characters and a maximum of 24 characters. Blanks are not allowed. For best security create a password with at least eight characters, including letters, numbers (0-9) and/or symbols. The default Administrator Password is “password”. If you forget your Administrator password after you have changed it, call your Beckman Coulter representative to reset it. Passwords and user access to the MXP software should be controlled. The software provides password related tools for use only by the System Administrator. The System Administrator can: r
Change the Administrator default password immediately and keep the new password in a secure location.
r
Enter the original Password for each User ID after installation of MXP 2.2. See Change This User’s Password for details.
r
Set the Password Timeout interval when a user’s password expires and must be changed.
r
Set the Password Failure Attempts limit.
r
Unlock the User ID and/or reset the password when the user exceeds the Password Failure Attempts limit and is locked out of the software.
Admin Button Allows access to the User Administration Tools, which allow the addition, removal and modification of User profiles and Workgroups, the creation of Export Billing Logs, the setting of time criteria for password changes, the setting of password failure attempts and the entry of the Cytometer serial number. Finish Button Allows access to the MXP software after a user has entered a correct password. Help Button Allows access to the online help for all non System Administrator MXP software screens.
3-4
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
3.3
SIGN-ON ADMINISTRATION User Administration Screen This screen allows the System Administrator to add, remove and modify User profiles, including passwords, as well as the creation of user Workgroups plus the creation of Export Billing Logs, setting up time criteria for user change of password, setting the limit of password failure attempts and the entering of the Cytometer serial number. Add User Modify User Delete User Workgroups Export Billing Information View Audit Trail Change Default Save Comments Archive Data Restore Archive Recover File From Archive Auto-Logout Timeout Password Timeout Password Failure Attempts Cytometer Serial Number
Add User Use this button to add a new user. See USER PROFILE – USER ID. Delete User IMPORTANT Deleting a User ID can cause loss of data. If you delete a User ID all the directories and files including listmode files that are in your Windows desktop under that User ID are deleted. Before deleting a User ID be sure to move or copy all needed directories and files for that User ID to different directories.
Highlight the User ID you wish to delete from the system and
.
A confirmation dialog box is displayed. Choose Yes to delete the user or No to revert to the User Access Control dialog box.
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3-5
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
Modify User Use this button to modify an existing user. See USER PROFILE – USER ID. Workgroups Selecting the Workgroup option allows the System Administrator to set up various Workgroups of your choice depending upon your requirements. Members of a Workgroup are allowed to easily share their directories on the Resource Explorer. Choose any names to suit your requirements and then enable the checkbox next to the names of users you wish to add to the Workgroup. Workgroup Selection Users Edit Button Within the display, ALL Users assigned to the system are shown BUT only those within the particular Workgroup shown in the Workgroup Selection box have the checkbox beside the User ID enabled.
See also: User Administration Screen Workgroup Selection Displays the current Workgroup. Select the drop down list box to display and select other Workgroups. Users Lists ALL the Users assigned to the system. Those with the checkbox activated by their User IDs are members of the particular Workgroup shown in the Workgroup Selection box. Users can be assigned to multiple Workgroups. To add a user to the Workgroup, click to enable the checkbox. To remove a user from the Workgroup, click to disable the checkbox. Edit Button Allows access to the Edit Workgroups screen.
3-6
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
Edit Workgroups This screen is used to Add or Delete specific Workgroup names. Add Delete
Add to add a new Workgroup to the system. Type the new Workgroup name in the Text Edit box and
.
Delete Highlight the appropriate Workgroup from the list displayed and to delete a particular Workgroup from the system. To edit the name of a particular Workgroup, first delete the Workgroup and then add it as a “new” Workgroup. See also: Workgroups User Administration Screen
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3-7
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
Export Billing Information Selecting the export billing option allows a text file log to be created showing the date and time each User has spent logged on to MXP software.
1
.
2
Enter the date range for the log and .
3-8
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
3
Select the users to include in the log and
4
.
Choose to direct the information to the Clipboard or to a File. If File is selected, you can either enter a valid File Name in the box or use the Browse Button to select an appropriate file. Select between Tab delimited (MS Excel default) or a Comma delimited text format file.
5
to end.
See also: User Administration Screen
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3-9
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE SIGN-ON ADMINISTRATION
View Audit Trail This feature is only available with the 21 CFR part 11 option. Change Default Save Comments This feature is only available with the 21 CFR part 11 option. Archive Data This feature is only available with the 21 CFR part 11 option. Restore Archive This feature is only available with the 21 CFR part 11 option. Recover File From Archive This feature is only available with the 21 CFR part 11 option. Auto-Logout Timeout This feature is only available with the 21 CFR part 11 option. Password Timeout Set the number of days (7 - 100) to define the time period when a user must change the password. Users are notified by the system when the time limit has been reached and are prompted to change the password before logging in. Password Failure Attempts Set the number of incorrect password attempts (2 - 5) that causes the user to be locked out of the MXP software. When a user is locked out due to failed password attempts, the System Administrator must unlock the user and enter a new password before the user can log back into the MXP software. Cytometer Serial Number Enter the serial number of the Cytometer (9-10 characters) connected to the Workstation.
3-10
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – USER ID
3.4
USER PROFILE – USER ID r
When a new user is added with the Add user button, or an existing one requires their details changed with the Modify user button, the following screen is displayed.
r
If you are modifying a user or changing the Administrator Password, the User ID/First Name/Last Name are grayed out.
r
If you migrated users from version 1.0 or 1.1 of MXP software, the User ID data you entered appears here.
User ID First Name Last Name Title/Description Training Info Privileges Access other files? Remember last accessed LMD directory? Overwrite acquired data files? Overwrite other data files? Add Absolute Calibration Batches Can Modify Custom Dyes? Status Change This User’s Password Print User Information
See also: USER PROFILE – PATHS User Administration Screen
User ID Enter a unique User ID for a new user. Previously used User IDs for deleted users cannot be reused. Existing User IDs cannot be modified. The Administrator name cannot be modified or deleted. User IDs are a minimum of 3 characters and a maximum of 24 characters.
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3-11
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – USER ID
First Name Enter the first name of the person for this User ID. Once entered, the first name cannot be modified or deleted.
Last Name Enter the last name of the person for this User ID. Once entered, the last name cannot be modified or deleted.
Title/Description Enter the user’s title or job description. This field can be changed as needed.
Training Info These features are only available with the 21 CFR part 11 option.
Privileges The System Administrator can assign various privileges, which allow or restrict a user’s ability to access and overwrite files, and the ability to add Absolute Calibration Batches.
Access other files? to enable the User to access other files. Leaving the box Unchecked allows access only to the User’s own Directories. Note: If a user opens protocols from other users folders and then wants to save the protocols to their own folder, the user must use the Save Protocol As option and navigate to their own folder and save the protocol.
Remember last accessed LMD directory? to allow the last accessed LMD (listmode) directory to be selected by that particular User. This option is available only if the Access other files? checkbox was enabled.
Overwrite acquired data files? to allow the overwriting of your acquired data files (listmode and histograms). If Access other files is enabled, enabling this checkbox allows overwriting any other User’s
acquired data files.
Overwrite other data files? to allow the user to overwrite their other files (protocols, panels, Worklists, and so on). If Access other files is enabled, enabling this checkbox allows overwriting any other User’s files.
3-12
PN 628899BB
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – USER ID
Add Absolute Calibration Batches to allow this user to enter and modify information available in the Analysis tt Absolute Count Calibration dialog box.
Can Modify Custom Dyes? This feature is not available with the MXP software.
Status Displays the current status of this User ID: Locked or Unlocked. r
r
Locked means this user cannot log into the MXP software. A User is locked: t
Until the System Administrator unlocks the User after setting up the User ID information for the first time.
t
Whenever the user reaches the defined number of unsuccessful password attempts allowed.
Unlocked means this user can log into the MXP software and access all of the privileges defined.
Change This User’s Password This feature allows you to assign a password: r
For the user’s initial log in to the system after installation,
r
Whenever a user forgets the current password, or
r
Whenever a user reaches the number of unsuccessful password attempts allowed.
The System Administrator cannot view user-created passwords.
PN 628899BB
3-13
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – USER ID
To change a user password:
1
2
Change Password.
Enter the new password in the Enter New Password field. Re-enter the new password in the Re-enter New Password field. Note: See Password for Password criteria.
3
OK.
Note: When a user enters this new password for the first time after the System Administrator changed the password, the system prompts the user to change their password immediately before logging into the MXP software.
Print User Information Print to print out the displayed information for this User ID. For your records, you can have the user verify the printed information and then sign the printout.
See also: User Administration Screen
3-14
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ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – PATHS
3.5
USER PROFILE – PATHS This screen allows the System Administrator to assign a Backup directory and displays the User directory Paths for different file types. The Backup directory may be any valid disk or Network area where files may be automatically archived. If a Backup directory is present, you are prompted with Archive Now on exiting the program, followed by an option to delete local files. Listmode files are stored in subdirectories titled with the Worklist Name, Date and Time under the LMD directory. Browsing Buttons Home Path Details Backup
See also: USER PROFILE – USER ID User Administration Screen Browsing Buttons The Browse Button allows browsing for a target directory. The Windows Explorer allowing you to browse for a directory name.
button opens
Home Shows the Home Directory Path that applies to that User. Path Details Shows the paths to the destination directories for the different File types within MXP software.
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3-15
3
ADMINISTRATOR’S TOOLS - STANDARD MXP SOFTWARE USER PROFILE – PATHS
Backup Shows the path to the Backup directory.
3-16
PN 628899BB
INDEX Symbols *.archive file definition, 2-19
Numerics 21 CFR Part 11 option, administrator tools, 2-1 option, install, 1-1 option, installation, 1-1 overview, 2-1 regulation, 2-1
A access other files? add user/modify user with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 add user/modify user access other files? with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 delete user with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 overwrite acquired data files with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 overwrite other data files with 21 CFR Part 11 option, 2-31 with standard MXP, 3-12 password with 21 CFR Part 11 option, 2-31 with standard MXP, 3-13 remember last accessed LMD directory with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 sign-on administration with 21 CFR Part 11 option, 2-29 with standard MXP, 3-11 user ID with 21 CFR Part 11 option, 2-30 with standard MXP, 3-11 user privileges with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 admin button signing on to MXP software with 21 CFR Part 11 option, 2-6 PN 628899BB
with standard MXP, 3-4 administration add user/modify user with 21 CFR Part 11 option, 2-29 with standard MXP, 3-11 create export logs with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 create user profiles with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 create user workgroups with 21 CFR Part 11 option, 2-7, 2-9 with standard MXP, 3-5, 3-6 export billing information with 21 CFR Part 11 option, 2-8, 2-11 with standard MXP, 3-8 tools, how to access with 21 CFR Part 11 option, 2-5 with standard MXP, 3-3 user access control paths with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 user ID available at installation with 21 CFR Part 11 option, 2-5 with standard MXP, 3-2 user ID, description with 21 CFR Part 11 option, 2-5 with standard MXP, 3-3 work with sign on passwords with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 workgroups, users with 21 CFR Part 11 option, 2-10 with standard MXP, 3-6 working with user profiles with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 administrator Beckman Coulter guide, how to access, 2-1 with standard MXP, 3-1 DaCS software guide, how to access, 2-3 tools with 21 CFR Part 11 option, 2-1 with standard MXP, 3-1 archive criteria, 2-19 files, 2-19 how to select a date, 2-23
INDEX-1
INDEX
LMD FCS keywords, 2-21 restore archived database, 2-25 Archive Now, 3-15 audit trail activity types, 2-13 overview, 2-13 printing considerations, 2-14 select criteria, 2-14 automated activity list of activities, 2-8 automatic log out how to set, 2-8 Autorun does not occur at installation, 1-5
B backup directory assign path with standard MXP, 3-15 display path with 21 CFR Part 11 option, 2-33 with standard MXP, 3-16 BCA&P archive files, 2-19 database size limits, 2-19 billing information export with 21 CFR Part 11 option, 2-8, 2-11 with standard MXP, 3-8 how to set up with 21 CFR Part 11 option, 2-8, 2-11 with standard MXP, 3-8 billing logs how to create with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 browsing buttons with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15
C comment See Save comments conventions used in the manual, xii Cytometer enter serial number with 21 CFR Part 11 option, 2-9
INDEX-2
with standard MXP, 3-10
D DaCS software administrator manual, 2-3 description, 2-3 installation, 1-1 log in, 2-6 log out, 2-6 setting up user IDs, 2-34 user ID requirements, 2-34 data files overwrite, acquired with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 overwrite, other with 21 CFR Part 11 option, 2-31 with standard MXP, 3-12 delete user, add user/modify user with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 workgroup with 21 CFR Part 11 option, 2-10 with standard MXP, 3-7 dialog box description, xiii documentation for your instrument about your instructions for use manual, xi conventions used, xii introduction to your manuals, xi using the manuals, xi
E electronic signatures restored archive files, 2-28 Excel software installation, 1-1 export billing information user administration with 21 CFR Part 11 option, 2-8, 2-11 with standard MXP, 3-8 export logs billing, how to create with 21 CFR Part 11 option, 2-11 with standard MXP, 3-8
PN 628899BB
INDEX
how to create with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5
F FC 500 MPL manuals, hard-copy, xi file how to archive, 2-19 finish button signing on to MXP software with 21 CFR Part 11 option, 2-6 with standard MXP, 3-4
G graphics for illustration only, xiii group See workgroups
H hidden files how to access, 2-1 histogram archive file, 2-19
I installation 21 CFR Part 11 option disk, 1-1 Excel software, 1-1 MXP software, 1-1 instructions for use manual information organization, xi using the manual, xi introduction to your manuals, xi
K keyboard use to select software commands, xiii
L license agreement 21 CFR Part 11 option disk, 1-3 listmode archive file, 2-19 PN 628899BB
lock user with 21 CFR Part 11, 2-31 with standard MXP, 3-13 log out automatic, 2-8 DaCS software, 2-6 log in after automatic log out, 2-2 logged in DaCS software, 2-6 signing on to MXP software with 21 CFR Part 11 option, 2-6 with standard MXP, 3-3
M manual updates, iii manuals for your instrument about your instructions for use manual, xi conventions used, xii how to use, xi introduction to your manuals, xi using the manuals, xi modify user ID with 21 CFR Part 11 option, 2-30 with standard MXP, 3-11 Multi-User Sign-On with 21 CFR Part 11 option, 2-4 with standard MXP, 3-2 MXP software installation, 1-1 path details with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 sign-on administration with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 standard, 3-1 See also software
N Not a Valid Worklist, 2-4, 3-2
O overwrite acquired data files add user/modify user with 21 CFR Part 11 option, 2-30
INDEX-3
INDEX
with standard MXP, 3-12 overwrite other data files add user/modify user with 21 CFR Part 11 option, 2-31 with standard MXP, 3-12
P panel archive file, 2-19 passwords add user/modify user with 21 CFR Part 11 option, 2-31 with standard MXP, 3-13 change user’s with 21 CFR Part 11 option, 2-31 with standard MXP, 3-13 failure attempt limit with 21 CFR Part 11 option, 2-9 with standard MXP, 3-10 how to create for sign on with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 set when it expires with 21 CFR Part 11 option, 2-9 with standard MXP, 3-10 signing on to MXP software with 21 CFR Part 11 option, 2-6 with standard MXP, 3-4 timeout with 21 CFR Part 11 option, 2-9 with standard MXP, 3-10 when to change with 21 CFR Part 11 option, 2-31 with standard MXP, 3-13 path details description with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 paths backup directory with 21 CFR Part 11 option, 2-33 with standard MXP, 3-16 display details with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 home directory with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15
INDEX-4
user access control paths with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 PDF archive file, 2-19 plate display appears at startup with 21 CFR Part 11 option, 2-4 with standard MXP, 3-2 privileges, user add user/modify user with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 protocol archive file, 2-19
R recover file from a restored *.archive file, 2-27 remember last accessed LMD directory add user/modify user with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 reporting units shown in US unit format, xiii restore archived files, 2-25 file from a restored *.archive file, 2-27
S Save comments default comments, 2-17 how to add, modify, remove, 2-17 serial number Cytometer, enter with 21 CFR Part 11 option, 2-9 with standard MXP, 3-10 signatures See electronic signatures signing on to MXP software sign-on administration with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 user ID with 21 CFR Part 11 option, 2-6 with standard MXP, 3-3 sign-on administration add user/modify user
PN 628899BB
INDEX
with 21 CFR Part 11 option, 2-29 with standard MXP, 3-11 signing on to MXP software with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 user administration with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 software license agreement, 21 CFR Part 11 option disk, 1-3 warning statement, xiii startup wizard description with 21 CFR Part 11 option, 2-4 with standard MXP, 3-2 status user ID with 21 CFR Part 11, 2-31 with standard MXP, 3-13
T timeout automatic log out, 2-8 password with 21 CFR Part 11 option, 2-9 with standard MXP, 3-10 training 21 CFR Part 11, 2-30 document training, 2-30 user profile, 2-30
U unlock user with 21 CFR Part 11, 2-31 with standard MXP, 3-13 user add with 21 CFR Part 11 option, 2-29 with standard MXP, 3-11 lock and unlock with 21 CFR Part 11, 2-31 with standard MXP, 3-13 modify with 21 CFR Part 11 option, 2-29 with standard MXP, 3-11 view all with 21 CFR Part 11 option, 2-10
PN 628899BB
with standard MXP, 3-6 See also user ID, user info user access control paths backup directory with 21 CFR Part 11 option, 2-33 with standard MXP, 3-16 general with 21 CFR Part 11 option, 2-33 path details with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 user administration create export logs with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 create user profiles with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 export billing information with 21 CFR Part 11 option, 2-8, 2-11 with standard MXP, 3-8 sign-on administration with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5 user access control paths with 21 CFR Part 11 option, 2-33 with standard MXP, 3-15 workgroups, description with 21 CFR Part 11 option, 2-9 with standard MXP, 3-6 workgroups, edit with 21 CFR Part 11 option, 2-10 with standard MXP, 3-7 workgroups, users with 21 CFR Part 11 option, 2-10 with standard MXP, 3-6 user ID add user/modify user with 21 CFR Part 11 option, 2-30 with standard MXP, 3-11 administrator with 21 CFR Part 11 option, 2-5 with standard MXP, 3-2, 3-3 at software installation with 21 CFR Part 11 option, 2-5 with standard MXP, 3-2 lock and unlock with 21 CFR Part 11, 2-31 INDEX-5
INDEX
with standard MXP, 3-13 signing on to MXP software with 21 CFR Part 11 option, 2-6 with standard MXP, 3-3 status, 2-31, 3-13 view all users with 21 CFR Part 11 option, 2-10 with standard MXP, 3-6 user name See user ID user privileges add user/modify user with 21 CFR Part 11 option, 2-30 with standard MXP, 3-12 user profiles create with 21 CFR Part 11 option, 2-7 with standard MXP, 3-5
edit the name with 21 CFR Part 11 option, 2-10 with standard MXP, 3-7 how to create with 21 CFR Part 11 option, 2-7, 2-9 with standard MXP, 3-5, 3-6 how to display and select with 21 CFR Part 11 option, 2-9 with standard MXP, 3-6 view users with 21 CFR Part 11 option, 2-10 with standard MXP, 3-6 worklist archive file, 2-19
V versions default, restored, 2-28 restore file screen, 2-27 restored as version one, 2-28
W Windows Explorer, use to browse with standard MXP, 3-15 how to access hidden files, 2-1 wizard startup, See startup wizard Workgroup Selection with 21 CFR Part 11 option, 2-9 with standard MXP, 3-6 workgroups add/remove user with 21 CFR Part 11 option, 2-10 with standard MXP, 3-6, 3-7 delete with 21 CFR Part 11 option, 2-10 with standard MXP, 3-7 description with 21 CFR Part 11 option, 2-9 with standard MXP, 3-6 edit with 21 CFR Part 11 option, 2-10 with standard MXP, 3-7
INDEX-6
PN 628899BB
TRADEMARKS The Beckman Coulter stylized logo is a trademark of Beckman Coulter, Inc. and is registered in the USPTO.
All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders.
PN 628899BB
Cytomics FC 500 MPL with MXP Software Documentation
s
Reference PN 177579
Use and Function • Installation • Specifications • Log Sheets • Using MXP Software • 21 CFR Part 11 Option Compliance Information • Glossary • Index
s
Special Procedures PN 177580
Cleaning Procedures • Replace/Adjust Procedures • Index
s
Instructions For Use PN 624813
System Overview • Daily Routine • Quality Control • Running Samples • Operation Principles • Troubleshooting • How To.... • Sample Plate Sizes • Index
s
System Administrator’s Guide PN 628899
Installation • Administrator’s Tools - With 21 CFR Part 11 Option • Administrator’s Tools - Standard MXP Software
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