In the last "Focus on Quality" column (1), I noted that the risk analysis methodology used in the GAMP Good Practices Guide for Validation of Laboratory Computerized Systems (GPG) (2), which was based upon failure mode effect analysis (FMEA), was too complicated. The rationale was that we purchase mostly commercial software in regulated laboratories that already has been tested by the respective vendor. Therefore, why do we need to potentially repeat work that has already been performed?
Before we begin this discussion, it is worth mentioning that I have written a paper on risk assessment at the system level, and determination of how much validation is required has been published recently by Advanstar Communications (3). This publication looked at the nature of the software used in the system and the impact of the records produced by the system to determine how much validation was required. The outcome if validation was required was one of two options: Full validation based upon a system implementation life cycle when the detailed steps to be undertaken are defined in a validation plan for the system. Lower-risk systems could be validated using a single integrated validation document that defined the intended use, security and access control, compliance issues, and preservation of the records produced by the system.
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1 comment:
Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation.more information
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