Access Limitations - 11​.10 (d)

21 CFR Part 11:

“(d) Limiting system access to authorized individuals.”

Procedures need to be defined that address system user administration, including who should be granted access and how that access is granted. Often systems require administrator level or otherwise high level users with great latitude in the actions they can perform within the system.

These high level users should get special attention when considering rules, limitations, and other procedural safeguards that can be applied.

Some customers may interpret the Part 11 guidelines to require a record of changes to user access profiles. InBatch records the creation or description change of a user or role profile but does not record the access details history. If required, a manual procedure should be established to create and maintain these records.