GXP

The Role of Critical Review in the Revision of Procedures | IVT

This article discusses a range of approaches to critical review of procedures, in terms of increasing credibility of the review findings.  It is management’s prerogative to weigh the benefits of increasing credibility against the costs of increasing rigor of the approach. This cost/benefit analysis must be informed by a determination of the degree of change that is involved in the revision, as well as a risk assessment of the change. After examining the critical review of SOPs, we  consider how the management of change depends upon a risk assessment.  It has three components:...

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