In the publication of the "Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application" in September 2003, the FDA explained its current interpretation of 21 CFR Part 11.

On 11 June 2004, the FDA will hold a public meeting in Washington D.C., on which it "would like public input to assist with their re-examination of part 11." In this context, the FDA intends to discuss the following points: the scope of part 11, risk-based approaches, validation, audit trails, record retention, record copying, and legacy systems.

On the 3 sub-chapters "General Provisions," "Electronic Records," and "Electronic Signatures," the FDA has already published several points for discussion in advance (Meeting Information).