Guidance on Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels (RiskVal)

Being able to cut back on the validation deliverables needed, and what is included in the deliverables is a major way to gain efficiencies in the validation process. This guidance document speaks to when a validation deliverable is needed for high, moderate, and low risk systems. It also addresses the level of rigor and intensity of the validation activities that are appropriate for systems at the 3 risk levels. The FDA recommends that the validation of the system be commensurate with the risk associated with the system. 9 pages

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This Guidance reviews all of the deliverables from each phase of the RiskVal validation process and identifies when each is needed based on system risk level and complexity. Guidelines are also provided on the level of rigor and intensity to be applied to deliverables for systems at the three risk levels.

This procedure is based on the RiskVal Life Cycle. (SM) It corresponds to the life cycle phases and deliverables described in The Computer System Risk Management and Validation Life Cycle written by the author of this procedure, Tim Stein, and published by Paton Press, 2006.

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