13/14 April 2021
GMP News No. 413
22 April 2004
Public Meeting onElectronic Records; Electronic Signatures (Part 11), 11 June 2004,Washington D.C.
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).