So the answer to the question is “yes,” SharePoint can be a validated application.

Does SharePoint need to be validated?

If your inspectable records are still paper-based, then you may not need to validate SharePoint at all. If your inspectable records are logically segregated from non-regulated documents (based on your SharePoint architecture), then you may only need to validate isolated sections of the system.

Is SharePoint FDA compliant?

Why You Should Use SharePoint For Compliance Issues Of FDA Regulated Industries. ... Summary: SharePoint provides the essential tools required by CFR 21, Part 11 such as audits, system validations, audit trails, electronic signatures and documentation.