Famulare: Revised Part 11 in 2007, But Risk-Based Focus Will Remain

Joseph Famulare, the FDA’s acting deputy director, Office of Compliance, and one of the agency leaders in advocating and articulating erecord integrity, discussed the state of 21 CFR Part 11 and the FDA’s once and future expectations Nov. 2 with PIR.

PIR: Do you expect the FDA to issue the revised Part 11 rule by the end of 2006?

Famulare: 2007 due to the regulations clearanceprocess is more realistic. It is hard to be more specific.

PIR: Should FDA-regulated companies press ahead with risk assessments and Part 11 compliance programs or should they wait to see what, if anything, is changed by the upcoming revision?

Famulare: The risk-based theme is emphasized in the current Scope and Applications Guidance and continues as a major theme from “The cGMP for the 21st Century” initiative. That focus will remain.

PIR: The FDA has not issued a warning letter citing Part 11 in some time. Some in industry believe it is not much of an enforcement issue at the agency now. Do you agree and, if so, will that change after the revision is issued?

Famulare: Having records that can be relied upon to perform their regulatory functions remains important.

If the records do not accurately reflect what has occurred or what was to be transcribed, where required by FDA laws and regulations, that will continue to need to be complied with and the agency can take regulatory actionif needed to bring about correction. This is spelled out again in the 2003 Scope and Applications Guidance.