Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C.

GMP News No. 413

22 April 2004

Public Meeting onElectronic Records; Electronic Signatures (Part 11), 11 June 2004,Washington D.C.

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

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

On the 3 sub-chapters "General Provisions," "ElectronicRecords," and "Electronic Signatures," the FDA has alreadypublished several points for discussion in advance (MeetingInformation).

Dr Andreas Mangel


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