Risk-Based Validation of Commercial Off-the-Shelf Computer Systems - Pharmaceutical Technology

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Risk-Based Validation of Commercial Off-the-Shelf Computer Systems


Pharmaceutical Technology


7. Pharmaceutical Inspection Convention, Good Practices for computerized Systems in Regulated "GXP: Environments, (DRAFT) (PIC/S, Geneva, Switzerland, Jan. 2002).

8. DIA/FDA Industry Training Session, May 2003.

9. H. Mollah, "Risk Analysis and Process Validation," BioProcess Int., 2 (9),(2004).

10. ISO 14971:2000, "Medical Devices—Application of Risk Management to Medical Devices," (ISO, Geneva, Switzerland, 2000).

11. Labcompliance, Risk Management Master Plan, 2004.

12. G. Stoneburner, A. Goguen, and A. Feringa, Risk Management Guide for Information Technology Systems. Recommendations of the National Institute of Standards and Technology," NIST Special Publication 800-30 (NIST, Gaithersburg, MD, July 2002).

13. PhRMA, "Letter to the FDA, Related to Proposed FDA Guidance on the Scope and Implementation of 21 CFR Part 11," on Oct. 29, 2001.

14. International Society for Pharmaceutical Engineering, White Paper, "Risk-Based Approach to 21 CFR Part 11," (ISPE, Tampa, FL, 2003).

15. J. Murray at the Institute of Validation Technology "Computer System Validation" conference, May 2004.

16. "Qualification and Validation," Annex 15 to the EU Guide to Good Manufacturing Practice, 2001.

17. ISPE, GAMP Good Automated Manufacturing Practice, Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures(ISPE, Tampa, FL, Feb. 2005).


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