FDA released its long awaited revision to the Guidance “Computerized Systems Used in Clinical Investigations”. This revision was originally awaiting the revision to the Part 11 regulation which has not yet occurred. The full guidance is at the link provided.

This guidance is less prescriptive and includes a great deal of flexibility in terms of security and audit trails and incorporates the concept of risk in determining what may be sufficient. Some of the items in this guidance are generally applicable to other types of computer systems that are subject to validation and/or Part 11.