TEMP005 Computer System OQ Template (RiskVal^SM)

This template provides extensive instructions and examples for each section of an OQ for a computer system. Of particular importance are information on OQ 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 7.3 Operational 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.