Sharepoint FDA Compliance

Under the U.S. Food and Drug Administration, some organizations are required to make electronic documents available for quality control audits. Accordingly, those who use Sharepoint must comply with FDA regulation 21 CFR Part 11, which speaks to maintaining authenticated electronic records.

Function

Sharepoint is a computer program that allows users from remote or distant locations to work collectively through a Web-based portal. Compliance with FDA 21 CFR Part 11 can be seen from governance tools that are built into the system, such as risk matrices and corporate compliance policies.

Education

Education and training prepares Sharepoint users with information about the FDA compliance standards. When outside auditors review Sharepoint files they look for usage of advanced reporting and audit trails, according to a June 2010 article on "Business Wire." Users must learn about revision and document controls, as well as how to validate data so that it is not considered fraudulent by external auditors.

Signatures

The FDA requires electronic documents to be authenticated with electronic signatures. Sharepoint users must validate their projects and files by adding electronic signatures in order to be in line with FDA expectations.

References

• Business Wire: InnovoCommerce LLC Announces Microsoft SharePoint 2010