Update on Part 11 in [Validation Times]

The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA :

1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of months to cover time stamps, archiving, e-copies of electronic records, and audit trails.

2. 26 warning letters with 44 citations issued as of May 21. 13 citations have been issued related to securiity and audit trails, 12 related to validation. 3. Tthe use of hand-held devices and web based systems and the relevance of 21 CFR Part 11 requirements is under discussion at FDA.

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