On 4 February, FDA withdrew the "Draft Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records," which had been published on 12 November 2002.
The reasons for this might lie with the fact that, due to the "CGMP Initiative" announced on 21 August 2002, the responsibility regarding 21 CFR Part 11 has been transferred from the Office of Regulatory Affairs (ORA) to the Center for Drug Evaluation and Research (CDER) headed by Joe Famulare. The industry has made a great number of comments as well as objections concerning the interpretation of Part 11 and the Draft Guidances.

Within the framework of the "CGMP Initiative", FDA now intends to use the time to possibly publish a modified version of the Guide.

Please click here in order to read the FDA statement on this measure (Docket No. 00D-1540).

Author:
Dr Andreas Mangel
CONCEPT HEIDELBERG

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• 21 CFR Part 11 Compliance - FDA Requirements on and Implementation of Electronic Records/Electronic Signatures, 12-13 May 2003
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