The Validation and Implementation of a Chromatography Data System 3

User acceptance testing (PQ) The user acceptance testing is concerned with the assurance that the functionalities specified in the user requirements specification (URS) are available and operate as specified by the vendor. Table II summarizes the test scripts produced for this phase of the validation.

Table IV: Individual instruments tested for use with the CDS.

Instrument tests In addition to the above functionality testing, qualification test logs were produced and executed for the individual instruments that would be operated in conjunction with Atlas. The instrument qualification was executed using a holistic approach. The test logs were designed to test that communication between the instruments, the Chromservers and Atlas could be established and maintained. Tables III and IV summarize the tests performed. Implementation Upon successful completion of the validation, release certificates were produced. The results of the validation effort at Covance, including the IQ/OQ results, were summarized in the Summary Report for Phase 1. This concluded that the application was found to meet the user requirements and was therefore fit for its intended purpose. Subsequently, Atlas was implemented into the Pharmaceutical Analysis Department. This implementation involved the following steps:

• installation of the Atlas Client on each of the user PCs with IQ testing for this step and complete documentation
• setting up the individual user accounts
• production of the relevant standard operating procedures (SOPs)
• training of the users

Validation documentation A whole suite of validation documentation was generated by this project. It was prepared by the user representatives, IT or the vendor. The documents were reviewed by QA to ensure that regulatory and procedural requirements had been met. The complete SDLC validation package comprised:

• a URS
• acquisition documentation: quotation, capital justification and special purchase requisition
• product documentation as deemed necessary
• vendor release documentation
• a completed supplier assessment questionnaire
• a validation plan
• IQ documentation
• OQ documentation
• additional OQ test scripts
• PQ
• a test plan (user acceptance plan)
• acceptance test logs
• a URS traceability matrix
• a validation summary report
• user manuals
• training material
• SOPs.

Conclusion This article illustrates the procedures involved in the successful validation and implementation of a chromatography data system as a replacement for an old system. The project involved the use of SDLC principles and the processes were documented at each stage. Resources from various departments across the company were required and, along with the tight deadlines imposed, careful planning and teamwork were essential from the start to achieve a successful outcome.
The phased approach adopted for this validation meant that the system hardware could be fully qualified and the software validated for the functionalities required for the Pharmaceutical Analysis Department. In reality, these included the major components of the application and allowed for the departmental-specific functions to be validated in Phase 2. This phased approach also meant that the implementation into the first user department could be achieved on schedule and with minimum disruption to project timelines. This made the subsequent deployment into the rest of the site a shorter and more manageable project.
Acknowledgements The authors would like to thank the many users involved in the validation and implementation of the CDS and Thermo LabSystems' Pathfinder services group for the installation and operational qualification documentation. The authors would also like to thank Bob McDowall from R D McDowall Consultancy Services for QualifyPlus documentation, on which part of this project was based.
References 1. "21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule," Federal Register 62(54), 13429-13466 (1997).
2. "Technical Report No. 18, Validation of Computer Related-Systems," PDA J. Pharm. Sci. Tech. 49(S1), S1-S17 (1995).
3. "Technical Report No. 33, Validation and Qualification of Computerized Laboratory Data Acquisition Systems," PDA J. Pharm. Sci. Tech. 53(4), 1-12 (1999).
4. R.D. McDowall, "Chromatography Data Systems III: Prospective Validation of a CDS," LC-GC Europe 12(9), 568-576 (1999).
5. R. Chamberlain, Computer Systems Validation for the Pharmaceutical and Medical Device Industries (Alaren Press, Inc., Libertyville, Illinois, USA, 1991).
6. "FIPS PUB 101, Guide for Lifecycle Validation, Verification, and Testing of Computer Software" (June, 1983).
7. T.D. Thompson et al., "The Prospective Validation of an MS Data System Used for Quantitative GLP Studies," LC-GC Europe 14(11) 687-694 (2001).
8. QualifyPlus Generic Chromatography Data System Validation Package, Version 3 (McDowall Consulting, Bromley, UK).