Risk management in computer validation is a hot topic since 2003 and the publication of the FDA's Part 11 Scope and Application guidance for industry stated "we recommend that you base your approach on a justified and documented risk assessment".
Risk management in computer validation is a hot topic since 2003 and the publication of the FDA's Part 11 Scope and Application guidance for industry stated "we recommend that you base your approach on a justified and documented risk assessment". Bob has written a review on the current regulatory position, the use of ISO 14971 terminology and approach plus the various risk assessment methodologies that can be applied to computerised system validation and IT infrastructure.