Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.
For starters, the investigation report must be designed for the reader, providing information and evidence that fully support the findings, conclusions, and actions. The report should relate a story that can be clearly understood by a third party months or even years after the event and the investigation. Read more advice from Smith and Elder in the May issue of PharmTech.