VAL005 Change Control for Validated Systems (RiskVal^SM)

Changes can destroy the work done to establish an effective computer system and to manage the risks associated with failure. To ensure that a change successfully fixes a problem or adds new capacity or capability to the system, the change is evaluated and approved. Appropriate testing is designed and conducted in a test environment, including ensuring that the change does not have unintended consequences. The test results are reviewed and the approval to make the change in the production environment is recorded. The roles of IT, QA/validation, and the system owner in the change management process are defined.

This procedure is part of the RiskVal Life Cycle^(SM) series of computer system validation documentation. It corresponds to the procedure described in "Deliverable 6.2 Change Control 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.