21 CFR 11 Overview of the Final Document and its New Scope Ludwig Huber - Pharmaceutical Technology

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21 CFR 11 Overview of the Final Document and its New Scope
Ludwig Huber
This article provides an overview of Rule 21 CFR Part 11's key requirements and its new, narrower scope.


Pharmaceutical Technology


3. International Society for Pharmaceutical Engineering (ISPE), The Good Automated Manufacturing Practices (GAMP) Guide for Validating of Automated Systems in Pharmaceutical Manufacture, GAMP4, (ISPE, Tampa, FL, 2001).

4. L. Huber, Validation of Computerized Analytical and Networked Systems, (Interpharm Press/CRC, Boca Raton, FL, 2002).

5. FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Applications (Draft Feb. 2003, Final Aug. 2003). Available at http:// http://www.fda.gov/cder/guidance/5667fnl.pdf.

6. ISPE, The Good Automated Manufacturing Practices (GAMP) Guide: Risk-Based Approach to Compliant Electronic Records and Signatures, (ISPE, Tampa, FL, 2005).

7. J.C. Famulare, "Current Status and Future Directions of Part 11," paper presented Sept 21, 2004.


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