The Validation and Implementation of a Chromatography Data System 2

In conjunction with the responses to the supplier assessment questionnaires, evaluations of each CDS were conducted. Each CDS was made available on-site for a period of a week. This meant that users were able to obtain hands-on experience of the application. Each application was objectively assessed by the users. This was done by completing a checklist, and scores were allocated for the following criteria:

• general appearance
• ease of use
• amount of training required
• ease of implementation
• instrument control
• handling of mass spectrometry data
• electronic record and signature implementation (21 CFR Part 11)
• connection to a laboratory information management system (LIMS)
• exporting data
• compatibility of data produced with Multichrom data.

The system user evaluations did not identify a clear 'winner.' The final decision was based on business criteria. These included compatibility with existing hardware and minimum potential disruption to the operating department during roll-out. Because of this, Atlas became the CDS of choice. The cost of implementation was low because the existing infrastructure hardware used for Multichrom could be used, as the software was compatible with Multichrom and therefore data migration would be simpler. Another contributory factor in favour of Atlas was the experience that Covance has had with the vendor for many years regarding CDS and LIMS products.

Table I: The key participants and responsibilities.

User acceptance testing (IQ/OQ) After the choice and purchase of Atlas as the required CDS, the key members of the validation team received training from Thermo LabSystems in the use of the software. For the user acceptance testing, a development environment was set up with access restricted to the validation team. The development environment was used to assess the functionality of the application and to allow for the preparation of the test logs. The application was then installed into an environment in which IQ/OQ/PQ and test logs were executed. An overall validation plan was generated that outlined the activities to be completed during the user acceptance phase. This included an introduction to what the project was aiming to achieve, the validation scope, definitions, system overview, roles and responsibilities of the project team, validation strategy and methodology, reporting and administrative procedures.
The operating environment comprised a Dell Poweredge Server 4400. The server uses two Pentium III 866 processors and has 1 GB memory, five 18 GB disk drives (with Raid 5 Stripping with Parity), 4 GB memory for the system drive and 65 GB memory for the Atlas system and data. The system is supported by an uninterrupted power supply (UPS 2200) and is located in a secure computer room, with access restricted to authorized personnel.

Table II: Tests for functionality.

The operating system is Windows NT Version 4.0, service pack 6a and the following co-installed software is present - Norton Antivirus software, Internet Explorer 5.5 and Netware Client Version 4.80. Arcserve open file agent is installed to enable the backup of open files. Installation and operational qualification was done by Thermo LabSystems personnel who were also responsible for the IQ and some OQ procedures and documentation. The IQ phase was concerned with formal assurance that the Atlas system (including software, hardware and Chromservers - the chromatography data acquisition device for Atlas) had been installed correctly. The activities undertaken during this phase were fully documented and comprised

• documenting the hardware (servers and clients)
• documenting the Chromservers
• executing the IQ tests

The IQ testing of the Atlas server and clients was successfully completed before the OQ and user acceptance testing (PQ) was started.

Table III: Tests for instruments.

The OQ phase ensures that the installed system works as specified by the vendor and sufficient documentary evidence exists to support this. This phase was mainly undertaken by Thermo LabSystems using the Atlas Validation Toolkit. The activities undertaken were fully recorded according to vendor documentation. In addition to the standard OQ tests, Covance ran separate OQ tests to check the capacity of the Chromservers, and the ability of Atlas to divert acquisition to another server (the Pick Up Server). This was required because in the event of there being a failure of the live Atlas server, data recovery is essential. The ability to cope with samples containing a number of named analytes within a workbook, containing a large number of injections, known as capacity testing, was also performed as part of the OQ. All the documentation produced by the vendor during the IQ and OQ phases was reviewed by a user representative and the IT group. It was also fully audited by the QA department.