VAL003 Validation of Computer Systems Used in Production and Quality Systems (RiskVal^SM)

ISO 13485 and Part 11 require that validations be conducted according to defined procedures. This procedure meets that requirement. It defines what the validation must include. The FDA recommends that the validation effort be in line with the risks associated with computer system failure. This procedure will save you time in your validations because it defines how to reduce what is done and the level of documentation for the validation for moderate- and low-risk systems.

This procedure is part of the RiskVal Life Cycle.^(SM) It corresponds to the procedure described in Deliverable 1.2 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 Press, 2006. This procedure is written WITHOUT using the phase concept of the RiskVal Life Cycle, but it includes the deliverables from the Life Cycle. This procedure includes the same deliverables as the procedure also available on this website, Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskVal Life Cycle), which DOES use the RiskVal Life Cycle as a framework.