software validation pack - beckman coulterinstruments. r the software provides controls to prevent...

Software Validation Pack

32 Karat 8.0

A33112ACMay 2012

Beckman Coulter, Inc.250 S. Kraemer Blvd., Brea, CA 92821

© Copyright 2006–2012 Beckman Coulter, Inc.

Copyright, Licenses and Trademarks

Copyright © 2006–2012 Beckman Coulter, Inc.

All rights reserved

No part of this document may be reproduced or transmitted in any form or by any means,

electronic, mechanical, photocopying, recording, or otherwise, without prior written permission

from Beckman Coulter, Inc.

Beckman Coulter and the stylized logo are trademarks of Beckman Coulter, Inc. and are

registered in the USPTO.

All other trademarks, service marks, products, or services are trademarks or registered trademarks of their respective holders.

Find us on the World Wide Web at: www.beckmancoulter.com

http://www.beckmancoulter.com

Table of Contents

Section 1 System OverviewIdentification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Compliance Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2Customer Base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

Section 2 Product HistoryHPLC Development/Release History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

The Evolution Begins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Version 1.0 March 1996 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3Version 1.5 June 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Version 1.6 September 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Version 1.7 March 1998 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Version 3.0 32 Karat Software August 1999 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4Version 3.1 July 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5Version 5.0 January 2001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6Version 7.0 April 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6Version 8.0 June 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

P/ACE MDQ Development/Release History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9MDQ Version 1.0, May 1997 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-932 Karat Software, Version 4.0 July 2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10Version 5.0 January 2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Version 7.0 April 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11Version 8.0 June 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12

ProteomeLab PA 800 Development/Release History . . . . . . . . . . . . . . . . . . . . . . . . . 2-1432 Karat Software, Version 7.0 April 2003 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14Version 8.0 June 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14

Section 3 Technical DescriptionComputer Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17Operating Software Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17Beckman Coulter, Inc., Directly Supported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

HPLC: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17Underlying Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

Section 4 Product DocumentationAdditional Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

Software Validation PackPN A33112AC i

Section 5 OptionsHardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

Section 6 Development EnvironmentProject Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23Software Product Development Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23Quality Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23Product Development Life Cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24Audits and Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Section 7 Support PoliciesWarranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Customer Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Product Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Updates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27Customer Feedback Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28

Section 8 Supplier InformationCompany Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29Financial Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29Product Specific Experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29

Appendix A Notices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1Supporting Beckman Coulter Procedures and Documents . . . . . . . . . . . . . . . . . . . . . . A-2

32 Karat 8.0A33112ACii

System OverviewIdentification

1

1System Overview

1.1 Identification32 Karat Workstation Software, Version 8.0 was released June 2006. The software version can be confirmed by selecting Help | About 32 Karat on the File Menu of the 32 Karat Software.

1.2 ManufacturerBeckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea, CA, USA 92821

1.3 Intended Use32 Karat Software is intended to be used as a single-point controller for Beckman Coulter HPLC, P/ACE MDQ, and ProteomeLab PA 800 systems and as a general chromatography data system for most HPLC and CE instruments featuring analog data outputs.

1.4 General DescriptionThe 32 Karat Software, Version 8.0 software package runs on the Windows XP operating system. It incorporates instrument control for Beckman Coulter HPLC, P/ACE MDQ, and ProteomeLab PA 800 systems with complete data acquisition, analysis, reporting and archiving capabilities.

The following general functions are provided:

Control - Bi-directional communication with Beckman Coulter's intelligent hardware modules is accomplished through a serial communications adapter. Software features include automatic system configuration, automatic systems shutdown, configurable instrument status and control, system suitability.

Acquisition - Data acquisition from Beckman Coulter’s intelligent hardware is accomplished digitally via the serial communication bus. There is no analog to digital or digital to analog conversion; System Gold hardware communicates with the PC hosting 32 Karat Software via an RS422 protocol. For HPLC and MDQ, data acquisition from other manufacturers’ equipment is accomplished through a 24-bit analog to digital converter SS420X device. Software features include real time system status and chromatogram display, audit trails for method and data files and acquisition of three dimensional diode array data.

Analysis - Software features include reliable integration algorithms with graphical or automatic setup, peak identification with reference peaks, up to 10 level linear or nonlinear calibrations, statistical analysis of batch runs and system suitability calculations.

Reporting - Software features include a completely user customizable report or pre-formatted report types, the ability to incorporate objects such as company logos into report templates, and results sign-off.

Software Validation PackPN A33112AC 1-1

System OverviewCompliance Features

1.5 Compliance FeaturesFeatures designed to assist the regulated laboratory in recording and providing documentation for compliance include the following:

r Key information, such as date/time, operator name, method used for collection, instrument configuration, original results and audit trail is saved in a single inseparable raw data file.

r All methods include both data acquisition and analysis parameters as well as instrument conditions when used with Beckman Coulter HPLC, MDQ, or PA 800 instruments.

r The software provides controls to prevent overwriting of data files, method and data file audit trails, and results sign-off.

r Each method has an imbedded audit trail stream where every change to the method is logged to identify the parameter that was changed and the old and new values along with the operator name, time and date.

r The software provides data files, methods, and audit trails in human readable and electronic forms suitable for inspection review and copying.

r The 32 Karat software system authenticates users based on both user name and password security. Rights to each function are assigned per individual by the system administrator.

r The 32 Karat software system provides an electronic signature feature which records the printed name of the signer, the date and time the signature was executed and the meaning of the signing. The signer’s identification is confirmed using a combination of user identification and password. The authority of signature is granted by the system administrator.

r The software system does not allow two users to have the same user name and password.

r In 32 Karat software, records are check summed and cannot be changed without revoking the signature, all of which is recorded in the audit trail. This checksum prevents the signature from being copied to another file.

r System Suitability parameters are calculated and stored as evidence of the proper system performance.

r System activity and error conditions are reported in a printable log.

1.6 Customer Base32 Karat software is installed in commercial, academic and governmental research, analytical services and quality control laboratories worldwide.

32 Karat 8.0PN A33112AC 1-2

Product HistoryHPLC Development/Release History

2

2Product History

2.1 HPLC Development/Release HistoryThe development and release history is described below for HPLC, P/ACE MDQ, and ProteomeLab PA 800 systems.

The Evolution BeginsThe evolution of chromatography workstation software within Beckman Coulter began in 1987 when System Gold software, based in the GEM operating system, was introduced for HPLC instrumentation.

Since introduction, this software product has demonstrated substantial problem-free usage in the field. Customer experience has demonstrated consistent conformance to system and software requirements and an absence of safety problems.

Version 1.0 March 1996This is the original release of Gold Nouveau Software. The following major features were included:

r Single point control with a Windows interface for ease of operation.

r Supports models 116, 118, 125, 126, 127 and 128 Pumps, 166 and 168 Detectors and the 502, 507 and 507e Autosamplers.

r Complete Methods for HPLC operation and data handling.

r Digital data acquisition for maximum data integrity.

r Reliable integration algorithms with automatic or graphical setup.

r Backward compatibility with older HPLCs.

r In the offline mode, any system configuration can be entered with the right mouse button.

r Methods are saved with the data file and cannot be overwritten.

r Password protected with restricted user access levels.

r Automatic Real Time Peak Purity display from the 168 Diode Array Detector.

r File names and Sample ID may be automatically incremented when creating a Batch Table.

r Chromatographics includes alignment to facilitate chromatogram comparisons by stretching or compressing.

r Independent scaling for A and B channels.

r Scientific notation used for Y-axis to accommodate CPM values.

r Retention time offset to permit alignment of chromatograms from detectors connected in series.

r Instrument window displays chromatogram, spectra and contour plot from the 168 Diode Array Detector in real time.



r Custom report formatting of results, chromatogram, header/footer, method and diode array data.

r Analysis can be performed during data collection.

r Calibration and unknown quantitation may be done using area and height.

r Results, chromatograms and spectra are easily exported with the choice of values, formats and statistics.

r Batch Table can run a shutdown method when a module becomes not ready (such as detector lamp out) or the disk fills up.

r Documentation of column and module serial numbers are allowed for GLP compliance.

Version 1.5 June 1997The following major feature was included:

r Integration of the SS420 board enabling the use of analog devices with Gold HPLC Systems.

Version 1.6 September 1997This was a bug fix released that addressed the following bugs:

r Implemented Holmium Oxide calibration for the 168 Diode Array Detector.

r Data compression bug fixes.

Version 1.7 March 1998The following major features were implemented:

r The 508 Autosampler functionality was added.

r Double Flow mode in the 126 Pumps was implemented.

r Ternary and Quaternary pumping systems were improved.

Version 3.0 32 Karat Software August 1999This major software release moves System Gold HPLC hardware control to the Windows NT software platform. Major features include:

r Single point control for up to 4 System Gold HPLC systems.

r Supports models 116, 118, 125, 126, 127, and 128 Pumps, 166 and 168 Detectors, 502, 507, 507e and 508 Autosamplers.

r Complete methods for HPLC operation and data handling.


r Backward compatibility with most older Beckman Coulter HPLC systems.

r Instruments can be created with any system configuration and opened in the offline mode for data reprocessing or method editing.

r The instrument configuration and the method used for data collection are saved with the data file and can not be overwritten.

32 Karat 8.0PN A33112AC 2-4


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r Data files and method files contain un-editable audit trails that can not be deactivated once turned on.

r Password protected with restricted administrator configured user access levels, with administration wizard for easy system administration.

r Automatic Real Time Peak Purity display from the 168 Diode Array Detector.

r File names and Sample ID may be automatically incremented by sequence line number, incremented number specified by the user, or date/time stamp, when creating or editing a Sequence Table.

r Long file names supported.

r Instrument window configuration and user preferences saved on a per user basis.

r All chromatographic operations including overlaying data files, addition, subtraction, multiplication, division, alignment, or stretching to facilitate chromatogram comparisons are performed from the Instrument window and can be included in reports.

r Unknown samples with concentrations outside specified limits may be reinjected up to 8 times.

r Independent scaling for all data channels.

r Scientific notation used for Y-axis to accommodate CPM values.

r Retention time offset to permit alignment of chromatograms from detectors connected in series.

r Instrument window displays chromatogram, spectra contour plot and 3D plot from the 168 Diode Array Detector in real time.

r Custom report formatting of results, chromatogram, header/footer, method, diode array data, results sign-off.

r Analysis can be performed at preset intervals or as required by the user during data collection.


r Results, chromatograms and spectra are easily exported with the choice of several values, formats and statistics.

r Sequence Table can run a shutdown method when a module becomes not ready (such as detector lamp out) or the disk fills up.

r Multiple Sequence runs or single runs can be added to a run queue with priority options.

Version 3.1 July 2001The following HPLC major features were added:

r The System supports both PCI and ISA Gold boards.

r System supports SS420X device.

r Intermittent problem with remote I/O of Gold board fixed.



Version 5.0 January 2001The following major features were added:

r The control function is combined for Beckman Coulter System Gold series HPLC instruments and P/ACE MDQ series CE instruments into a single software package.

r Any combination of HPLC and CE components up to four are allowed.

r A new PDA data analysis package is incorporated into 32 Karat v5.0.

r The system runs with full functionality on both Windows 2000 and Windows NT 4.0.

r Improved Help instructions.

r Advanced reports.

r Advanced Electronic Signature feature.

r Global Method Audit Trail trigger.

Version 7.0 April 2003The following major features were added:

r The control function is combined for Beckman Coulter System Gold series HPLC instruments, P/ACE MDQ series CE instruments, ProteomeLab PF 2D and ProteomeLab PA 800 instruments into a single software package.

r The system runs with full functionality on Windows 2000.

r The sequence wizard for P/ACE MDQ has been enhanced to facilitate the fill down function of the sample injection vial. It is no longer required to manually type in all injection vial positions.

r A configuration converter has been implemented that checks the previous Instrument Configuration versions and modifies the Type ID to that of Version 7.0. This will help 32 Karat 7.0 software to properly recognize the Instrument Type ID and display the appropriate configuration settings.

r A system activity log has been added to the main window of the software. This activity log is similar to the instrument activity logs, currently available for each configured instrument, but tracks user administration level activities.

r An audit trail to log changes made to sequences has been added. The characteristics of the sequence audit trail feature are similar to the method audit trail feature currently available in the software.

r Administrative Mode Timeout has been implemented. This feature will automatically log out from system administration mode after a user-specified period of inactivity. The user has the ability to disable this feature as well as to specify the time of inactivity that triggers the lockout.

r Electronic Data Signature function has been enhanced. Fixed hierarchical roles and rules for approval and revocation of signatures have been added. These roles are discrete permissions that can be assigned to users and will control how electronic signatures can be applied and revoked. When an electronic signature is applied to a data file, the signer will be able to choose a reason from a fixed list specified by the system administrator. When an electronic signature is applied to a data file, the signer will be able to enter an optional, free form text comment. The inactivity

32 Karat 8.0PN A33112AC 2-6


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timeout for closing an in-process signature may now be configured in system options. When an electronic signature is applied the users full legal name (if associated within the domain) will be applied to the signature.

r Extract configuration from data file. The 'Open with Configuration' option in the File Open dialog has been replaced by an option in the initial instrument configuration screen that enables the user to load instrument configuration settings from a stored data file.

r New Baseline Check feature has been implemented. There is a new baseline check option that lets you enable a check for noise and drift on a detector baseline prior to the run start. If the check fails, the run will not occur.

r AIA Import feature has been enhanced. The software now supports irregular point spacing in the import of AIA format data files.

r Functionality of the photodiode array control option has been enhanced:

r Enhancements to Spectrum View to allow annotation of the graph with 3-lambda max and/or 3 lambda min values.

r Additions to Action Button, to include Add to MultiChromatogram Table and Add to Spectrum Library.

r Additions to Options Button to add Show Peak Purity Plot.

r User Interface Interactions Between Panes: Displaying the Peak Apex Spectrum from the Contour Pane Accomplished by dragging and releasing the static cursor on a detected peak in the chromatogram/electropherogram pane while holding down the Control key.

r The Add Spectrum to Library mode allows the user to easily extract spectra from a chromatogram and add them to a spectrum library. The user enters this mode by selecting Add Spectrum to Library from the Actions menu.

Version 8.0 June 2006The following features were added:

r A USB flash drive license is now used. The software licenses for previous versions were installed from a diskette and have been replaced by a USB hardware license. This license is portable and does not require uninstalling.

r Range annotations for Groups have been enhanced. In addition, there was no range bar that displayed the group's range. This new feature will display the group name only once, at the right side of the group's range bar. The range bars' start, stop, and position can be graphically updated. The changes are reflected in the Group Table.

r Graphical adjustments of retention time window (annotated as RT Window) has been enhanced. The user can graphically change the RT Window's start, stop and position, using the graphical toolbar icons at the bottom of the instrument screen. The changes are then reflected in the Peak Table.

r Post-export user program has been enhanced. Users can now launch custom programs at the very end of the post-run acquisition. This allows users to export data, and then have the custom program look at the exported information.

r Mandatory Audit Trails have been enhanced to allow turn on audit trailing on a project-by-project basis, through the System Administration Wizard, for methods



and sequences. This enhancement allows the user to also activate the audit trails on a project by project basis.

r Default project lockout has been added. This enhancement makes it possible to create new projects even if the Default project is missing. This feature also allows creation of new projects even when the Default/Template directory has been deleted.

r Peak centroid calculation has been added. This feature calculates the "mean" time for the area of a peak.

r Single user login has been added. When using project login, this feature allows to user to specify that the computer user's login (domain or local) can be used to automatically log into instruments and projects that the user has rights to. It can also be specified so that a user can login once to an instrument, then not be required to log into any other instruments.

This feature allows users to:

r Login to the first instrument, then not have to login to any others; they would just open.

r Allow the user to use their computer login in place of the instrument/project login.

r HPLC signal to noise ratio has been enhanced. The signal to noise ratio for a given peak in a data file will the same for a given peak, regardless if the peak ID table is active or not.

r HPLC retains function after the application has been closed. When an HPLC instrument is exited and re-opened, the pump flow rate will remain on and at the same flow rate prior to exiting and the pump solvent position will remain the same as that prior to exiting. This is how HPLC instruments worked prior to 32 Karat software version 7.0.

32 Karat 8.0PN A33112AC 2-8

Product HistoryP/ACE MDQ Development/Release History

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2.2 P/ACE MDQ Development/Release HistoryP/ACE MDQ Software was introduced in May 1997.

Since introduction, this software product has demonstrated substantial problem-free usage in the field. Customer experience has demonstrated consistent conformance to system and software requirements and an absence of safety problems.

MDQ Version 1.0, May 1997This is the original release of P/ACE MDQ Software. The following major features were included:

r Single point control with a Windows 95 interface for ease of operation.

r Complete Methods for CE operation and data handling.

r Digital data acquisition for maximum data integrity.


r Methods are saved with the data file and cannot be overwritten.

r Password protected with restricted user access levels.

r File names and Sample ID may be automatically incremented when creating a Batch Table.

r Includes alignment to facilitate electropherogram comparisons by stretching or compressing.

r Custom report formatting of results, electropherogram, header/footer, method and diode array data.

r Analysis can be performed during data collection.


r Results, electropherograms and spectra are easily exported with the choice of values, formats and statistics.

r Batch Table can run a shutdown method when a module becomes not ready (such as detector lamp out) or the harddisk is full.

Version 1.1 June 1997The following major feature was included:

r Addition of analog output.

Version 1.2 September 1997The following major features were included:

r Improvements to voltage ramping.

r Addition of time programming features.



Version 1.5 April 1998The following major features were included:

r Analog scaling.

r Shutter control.

r 96-well tray positioning.

r Simultaneous pressure.

Version 1.6 February 1999The following major features were included:

r Automatic pressure ramp-down.

r Support for faster PC systems.

r Support for hardware improvements.

Version 2.2, May 1999The following major features were included:

r Support for LIF detection.

r Improvements to user interface for Caesar algorithm.

Version 2.3, August 1999The following major features were included:

r Support for faster PC systems.

32 Karat Software, Version 4.0 July 2000 r This major software release moves P/ACE MDQ hardware control to the Windows

NT software platform. Major features include:

r Runs on Windows NT 4.0 platform. Windows 95/98 not supported.

r Written 100% in 32 bit code.

r Requires considerably more PC power than MDQ v2.3. See Section 3.0.

r Sequence Table (replaces MDQ Batch Table.)

r Supports up to 4 MDQ PDA systems on one PC.

r Supports long file names.

r Mobility plots are supported.

r Peak ID by retention time, migration time and mobility.

r 2D peak Identifier (mobility and spectrum.)

r Replicate injections have rep1, rep2, etc. appended to file name. (Replicate injections in MDQ have r1, r2, etc. replacing 7th and 8th characters in filename.)

r User can choose Peak Detection method: Caesar algorithm or slope threshold (MDQ used Caesar only.)

r Status display is interactive (was display only.)

32 Karat 8.0PN A33112AC 2-10


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r Unlimited ability to overlay electropherograms. Stored traces can be overlaid on real-time plots during data acquisition.

r Automatic compression of 3-D data files.

r Allows post-run display of electropherogram with mobility as the x-axis.

r Enhanced report generation capabilities.

Version 5.0 January 2002The following major features were added:

r The control function is combined for Beckman Coulter System Gold series HPLC instruments and P/ACE MDQ series CE instruments into a single software package.

r Any combination of CE and HPLC components up to four are allowed, with the single limitation that the total number of HPLC PDA detectors on a workstation may not exceed two (four MDQ PDA detectors may be used.)

r A new PDA data analysis package was incorporated.

r The system runs with full functionality on both Windows 2000 and Windows NT 4.0.

r Improved Help instructions.

Version 7.0 April 2003The following major features were added:

r The control function is combined for Beckman Coulter System Gold series HPLC instruments, P/ACE MDQ series CE instruments, ProteomeLab PF 2D and ProteomeLab PA 800 instruments into a single software package.


r The sequence wizard for P/ACE MDQ has been enhanced to facilitate the fill down function of the sample injection vial. It is no longer required to manually type in all injection vial positions.

r A configuration converter has been implemented that checks the previous Instrument Configuration versions and modifies the Type ID to that of Version 7.0. This will help 32 Karat 7.0 software to properly recognize the Instrument Type ID and display the appropriate configuration settings.

r A system activity log has been added to the main window of the software. This activity log is similar to the instrument activity logs, currently available for each configured instrument, but tracks user administration level activities.

r An audit trail to log changes made to sequences has been added. The characteristics of the sequence audit trail feature are similar to the method audit trail feature currently available in the software.

r Administrative Mode Timeout has been implemented. This feature will automatically log out from system administration mode after a user-specified period of inactivity. The user has the ability to disable this feature as well as to specify the time of inactivity that triggers the lockout.

r Electronic Data Signature function has been enhanced. Fixed hierarchical roles and rules for approval and revocation of signatures have been added. These roles are



discrete permissions that can be assigned to users and will control how electronic signatures can be applied and revoked. When an electronic signature is applied to a data file, the signer will be able to choose a reason from a fixed list specified by the system administrator. When an electronic signature is applied to a data file, the signer will be able to enter an optional, free form text comment. The inactivity timeout for closing an in-process signature may now be configured in system options. When an electronic signature is applied the users full legal name (if associated within the domain) will be applied to the signature.

r Extract configuration from data file. The 'Open with Configuration' option in the File Open dialog has been replaced by an option in the initial instrument configuration screen that enables the user to load instrument configuration settings from a stored data file.

r AIA Import feature has been enhanced. The software now supports irregular point spacing in the import of AIA format data files.

r Functionality of the photodiode array control option has been enhanced:

r Enhancements to Spectrum View to allow annotation of the graph with 3-lambda max and/or 3 lambda min values.

r Additions to Action Button, to include Add to MultiChromatogram Table and Add to Spectrum Library.

r Additions to Options Button to add Show Peak Purity Plot.

r User Interface Interactions Between Panes: Displaying the Peak Apex Spectrum from the Contour Pane Accomplished by dragging and releasing the static cursor on a detected peak in the chromatogram/electropherogram pane while holding down the Control key.

r The Add Spectrum to Library mode allows the user to easily extract spectra from a chromatogram and add them to a spectrum library. The user enters this mode by selecting Add Spectrum to Library from the Actions menu.






32 Karat 8.0PN A33112AC 2-12


2

r Mandatory Audit Trails have been enhanced to allow turn on audit trailing on a project-by-project basis, through the System Administration Wizard, for methods and sequences. This enhancement allows the user to also activate the audit trails on a project by project basis.







r In P/ACE MDQ, the Qualitative Analysis Report has been enhanced in the following three areas; 1) the Y axis is on scale; 2) the type of curve fit now matches the line drawn; and 3) mobility values have sufficient decimal units to show a significant mobility value.

r In MDQ, the units for drift in the Suitability set up table and in the report are now Drift/Min.

r In MDQ, the sequence wizard has been enhanced so when the Advance box is unchecked, the outlet vial does not advance for the calibration vial. When the Advance box is checked, the outlet vial does advance for the calibration vial.

r In MDQ, mobility values calculated with the LIF detector is now in the same units as the mobility values for the UV and PDA detector.


Product HistoryProteomeLab PA 800 Development/Release History

2.3 ProteomeLab PA 800 Development/Release HistoryThe ProteomeLab PA 800 instrument was introduced in June 2003.

32 Karat Software, Version 7.0 April 2003This is the original software release for the ProteomeLab PA 800 system. Major features include:


r Supports PA 800 instruments and its applications. Applications include: peptide mapping, carbohydrate analysis, isoelectric focusing, and SDS-Gel MW analysis.

r Any combination of PA 800, MDQ and HPLC components up to four are allowed, with the single limitation that the total number of HPLC PDA detectors on a workstation may not exceed two (four PA 800 PDA detectors may be used.)






r Mandatory Audit Trails have been enhanced to allow turn on audit trailing on a project-by-project basis, through the System Administration Wizard, for methods and sequences. This enhancement allows the user to also activate the audit trails on a project by project basis.




32 Karat 8.0PN A33112AC 2-14


2




r In ProteomeLab PA 800, the Qualitative Analysis Report has been enhanced in the following three areas; 1) the Y axis is on scale; 2) the type of curve fit now matches the line drawn; and 3) mobility values have sufficient decimal units to show a significant mobility value.

r In PA 800, the units for drift in the Suitability set up table and in the report are now Drift/Min.

r In PA 800, the sequence wizard has been enhanced so when the Advance box is unchecked, the outlet vial does not advance for the calibration vial. When the Advance box is checked, the outlet vial does advance for the calibration vial.

r In PA 800, mobility values calculated with the LIF detector is now in the same units as the mobility values for the UV and PDA detector.



32 Karat 8.0PN A33112AC 2-16

Technical DescriptionComputer Hardware Requirements

3

3Technical Description

3.1 Computer Hardware Requirements32 Karat software version 8.0 was validated on the following workstation:

3.2 Operating Software RequirementsOperating System: Windows XP with Service Pack 2

3.3 Beckman Coulter, Inc., Directly Supported32 Karat 8.0 Software is designed to communicate directly with the following Beckman Coulter instruments:

HPLC: r 116 Programmable Solvent Module with Version 3.1 firmware or greater

r 118 Programmable Solvent Module with Version 3.3 firmware or greater





r 166 Programmable Detector Module with version 3.0 firmware or greater

r 168 Programmable Detector Module with version 2.0 firmware or greater

r 502 Autosampler with Version 1.17 firmware or, when equipped with a keyboard: Version 3.54 firmware

r 507 Autosampler with Version 6.16 firmware or greater

r 507e Autosampler with Version 1.25 firmware or greater

r 508 Autosampler with software version 1.03 or greater

r P/ACE MDQ Capillary Electrophoresis systems with version 5.0 firmware or greater

r ProteomeLab PA 800 systems with factory-installed firmware

Processor Pentium IV processor, 3.2 GHz

Disk Size 40 GB

Memory 1 GB RAM

Input Devices DVD-RW, USB Port

SVGA Video Display 1024 x 768 resolution

Printers Windows XP compatible printer


Technical DescriptionUnderlying Database

3.4 Underlying DatabaseODBC data export supported.

32 Karat 8.0PN A33112AC 3-18

Product DocumentationAdditional Literature

4

4Product Documentation

4.1 Additional LiteratureThe 32 Karat Online Help is integrated with the software.

Software Migration Guide (PN 715093)

System Manuals are shipped with each instrument.


Product DocumentationAdditional Literature

32 Karat 8.0PN A33112AC 4-20

OptionsHardware

5

5Options

5.1 Hardware Instruments featuring analog outputs are supported through the SS420X analog-to-digital device.

5.2 SoftwareA Reprocessing Key is available for data manipulation without instrument control, PN A33039.


OptionsSoftware

32 Karat 8.0PN A33112AC 5-22

Development EnvironmentProject Identification

6

6Development Environment

6.1 Project IdentificationProject Name: 32 Karat 8.0

Development Center: Life Science Discovery and Lab Automation, Indianapolis, IN, USA

6.2 Software Product Development EnvironmentConfiguration Management System: Source Safe 5.0

Source Language: C++

Compilers: MSVC C++ 6.0

Operating System: Windows XP

Prototype and Simulation Tools: None

Software Metric and Evaluation Tools: QA Partner

6.3 Quality Management System32 Karat Software, Version 8.0 was designed, evaluated, validated, inspected and tested to approved specified Quality requirements of Beckman Coulter, Inc., in accordance with the following:

r ISO 9001: 2000 Certified Quality Management System certificate number 19.0063 issued by the National Standards Authority of Ireland (NSAI).

It is further certified that:

r The software was developed, verified, and controlled by qualified professionals.

r Source code is annotated and contains unique version control identification.

r All source code, development tools, and production documentation are archived for reasonable periods with all necessary version control information retained and with archive tapes secured in an off-site vault.

r Documentation for error reports and error report management are retained at the Fullerton facility.


Development EnvironmentProduct Development Life Cycle

r Operational software has been monitored to verify continuing compliance with system and software requirements, to provide proper tracking, review, disposition, and testing of system errors in post-release software, and to provide for prompt notification of affected customers.

6.4 Product Development Life Cycle32 Karat Software was developed following the Beckman Coulter, Inc. Product Development Cycle described in Procedure Document BMRDP-200. A model of this process is depicted in the figure below. The processes used to manage and control the development phase activities and interfaces are included in the Product Development Cycle Description. The Problem Report Process, BMRDP-430 is used to document, manage and control all changes resulting from errors encountered during the development phases.

32 Karat 8.0PN A33112AC 6-24

Development EnvironmentAudits and Reviews

6

6.5 Audits and ReviewsCustomer reviews and audits of Beckman Coulter, Inc. software development procedures, documentation, and source code for the purpose of complying with regulatory requirements related to software validation or verifying the quality management system, are available by contacting the Quality Manager for the Fullerton site.

Beckman Coulter, Inc., will maintain possession of all documents and their reproductions and may require a non-disclosure agreement to be provided by those requiring access to these documents.


Development EnvironmentAudits and Reviews

32 Karat 8.0PN A33112AC 6-26

Support PoliciesWarranty

7

7Support Policies

7.1 WarrantyThe subject software product is warranted on an "as is" basis without fitness for any specific purpose with the exception of the media that is warranted against defects in materials or workmanship for a period of one year.

7.2 InstallationInstallation of the 32 Karat Software on an appropriate personal computer is available through the Service organization at the time of installation of the 32 Karat Workstation. Installation is performed by trained engineers.

7.3 Customer TrainingUp to four hours of in-lab training (for a maximum of two operators) is included with the purchase of the 32 Karat Chromatography Workstation and software. Training is performed by trained field engineers or product specialists.

7.4 Product SupportSoftware support via telephone is provided through field offices worldwide for all purchasers of the 32 Karat Chromatography Workstation.

7.5 UpdatesFrom time to time, Beckman Coulter, Inc., updates the subject product to incorporate new features, support new devices or to implement corrective actions. To the greatest reasonable extent, but at the sole discretion of Beckman Coulter, Inc., updated versions are compatible with data and method files, instrument and PC hardware used and/or created by the immediately preceding version. Such new versions are available to both existing and potential customers. Contact your local sales representative for current 32 Karat update information.


Support PoliciesCustomer Feedback Reporting

7.6 Customer Feedback ReportingAll Customer Feedback reported for released versions of software are handled according to the Beckman Coulter, Inc., Customer Feedback Procedure Document, BCP001 and the Brea Customer Feedback Process, BMRFIPA 8.5.001.

The process model is depicted in the following figure:

32 Karat 8.0PN A33112AC 7-28

Supplier InformationCompany Description

8

8Supplier Information

8.1 Company DescriptionBeckman Coulter, Inc., designs, manufactures, markets and services a broad range of laboratory systems, reagents and related products, that address the needs of diagnostic laboratories as well as bioanalytical laboratories in the life science market, including those in universities, research institutes, pharmaceutical companies and biotechnology companies. Generally, the Company's products simplify and automate laboratory processes, saving time and money.

Products for clinical diagnostic laboratories include general and special chemistry systems together with reagents, accessories and software that are used to detect and quantify various substances of clinical interest in human blood and other body fluids. Products for life science laboratories include centrifuges, high performance liquid chromatography, spectrophotometers, laboratory robotic workstations, capillary electrophoresis systems, nuclear counters, protein sequencers, DNA synthesizers and the reagents and supplies for their operation. Beckman Coulter, Inc., supports its products with a worldwide sales and service network.

8.2 Financial Highlights

Beckman Coulter, Inc., is a publicly owned company incorporated in Delaware. Common shares are traded on the New York Stock Exchange. The company maintains offices or authorized sales and service representation in numerous countries throughout the world.

For additional information or a current annual report to the shareholders, contact:

Beckman Coulter, Inc.Director, Shareholder Services250 S. Kraemer Blvd.Brea, California 92821

8.3 Product Specific ExperienceBeckman Coulter, Inc. has been a manufacturer of analytical instrumentation since being founded in 1936. Beckman Coulter, Inc. has been developing and manufacturing high-performance separation instrumentation for over 40 years.

Years Ended Dec. 31. (Dollars in Millions)

2001 2002 2003 2004 2005

Sales $1,984 $2,059 $2,193 $2,408 $2,444


Supplier InformationProduct Specific Experience

32 Karat 8.0PN A33112AC 8-30

Appendix ANotices

A

AAppendix A

A.1 NoticesThis information presented here, although believed to be correct at the time of approval, is not warranted for accuracy or completeness. Some of the information presented here is subject to change without notice.

Unless explicitly noted herein, direct questions for additional detail, current status or corrections and classifications to:

Beckman Coulter, Inc.Quality Manager250 S. Kraemer Blvd.Brea, CA 92821

Software Validation PackPN A33115AC A-1

Appendix ASupporting Beckman Coulter Procedures and Documents

A.2 Supporting Beckman Coulter Procedures and DocumentsBeckman Coulter, Inc., will maintain possession of all documents and their reproductions, and may require a non-disclosure agreement to be provided by those requiring access to these documents.

32 Karat 8.0PN A33112AC A-2