TEMP006 Computer System PQ Template (RiskVal^SM)

This template can be used for the four types of PQ testing described in Chapter 10 of Computer System Risk Management and Validation Life Cycle: dual systems, confirmation, system tests, and system monitoring. This template provides extensive instructions and examples for each section of a PQ for a computer system. Of particular importance are information on PQ prerequisites, acceptance criteria, and the test section. Instructions and examples are provided for the following parts of the test section: backward traceability to the requirements tested, tests, and identifying user setup requirements and test data for the protocol.

Also included are instructions on how to execute the protocol, and a variance form with instructions.

This template is part of the RiskVal Life Cycle (SM) series of computer system validation documentation. It corresponds to the protocol described in "Deliverable 8.1 Performance Qualification Protocol" in Appendix A of Computer System Risk Management and Validation Life Cycle written by the author of this template, Tim Stein, and published by Paton Professional, 2006.