White Paper: Automating Spreadsheet Controls For 21 CFR Part 11 Compliance

By Prodiance Corporation

In 2003, the U.S. Food & Drug Administration (FDA) issued their latest guidance on 21 CFR Part 11 regarding compliance for electronic records: Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application. This document was a follow-up to the original ruling for 21 CFR Part 11 issued in August of 1997, and represents the "FDA's current thinking on this topic" for companies who maintain electronic records or submit information to the FDA that are subject to Part 11 mandates. Although the 2003 guidance clarified (and perhaps somewhat relaxed) the FDA's interpretation of Part 11 requirements, they promised that regulatory action would be taken for any non-compliance.