VAL004 Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (RiskVal^SM)

The purpose of validation is to gather objective evidence that the system reliably functions to meet requirements. An appropriate definition of requirements is the foundation of the validation. The common practice in regulated industries is to define how the computer system validation will be conducted in a validation plan; to verify the proper installation of the computer system and that the hardware and system software meet technical requirements in an IQ; to test functions in a validation environment in the OQ; and verify that the system meets requirements as used in the company process in a PQ. Protocol reports review the results of each of the three qualifications. The validation effort is reviewed and a discernment is made as to the suitability of the system in the validation final report. This procedure defines the content requirements for requirements documents, the validation plan, IQ, OQ, and PQ protocols, protocol reports, and the validation final report.

This procedure is part of the RiskVal Life Cycle.^(SM) It corresponds to the procedure described in "Deliverable 1.4 Requirements for Computer System Validation Plans, Protocols, and Reports Procedure" in Appendix A of Computer System Risk Management and Validation Life Cycle written by the author of this procedure, Tim Stein, and published by Paton Professional, 2006.