Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee. As of January 2001: 1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final. 2. FDA has suspended...Read More

In 2000, a coalition of trade associations was formed to provide input to FDA regarding interpretation of Part 11. This unusual effort across industries has been undertaken due to the global nature of the rule and the cost and impact of compliance to the rule depending on interpretation. The initial group of six national trade...Read More