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://
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.