A Perspective on Computer Validation - Pharmaceutical Technology

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A Perspective on Computer Validation
This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.


Pharmaceutical Technology


10. Australian Therapeutic Goods Administration, Code of GMP for Medicinal Products, Annex 11 Computerised System (2002), http://www.tga.gov.au/docs/pdf/gmpcodau.pdf.

11. Concept Paper on Computerised System Guidelines (2006), http://www.emea.eu.int/Inspections/docs/51857706en.pdf.

12. 21 CFR Part 211.186 Master Production and Control Records, http://www.fda.gov/cder/dmpq/cgmpregs.htm.

13. FDA Electronic Identification/Signature Working Group Progress Report (1992), http://www.fda.gov/ora/compliance_ref/part11/FRs/background/esigrpt1.pdf.

14. "FDA Revoking Existing Part 11 Guidelines and Replacing with the Draft Scope and Application Guideline," Fed. Register (Feb. 25, 2003), http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf.

15. Guidance for Industry, Part 11 Electronic Records, Electronic Signatures, Scope and Application (2003), http://www.fda.gov/cder/guidance/ 5667fnl.htm.

16. G. Smith, FDA Compliance Safety Officer, CDER, presentation at GAMP Conference in Washington DC, June 2007.

17. A.S. Clark, "Computer Systems Validation: An Investigator's View," Pharm. Technol. 12 (1), 60 (1988).

18. PDA Audit Resource Center, http://www.pda.org/webmodules/webarticles/templates/new_professional_audit.aspx?articleid=111&zoneid=62.

19. FDA Part 11 Compliance Committee's Summary of the Public Conference on the Technical Implementation of 21 CFR Part 11, http://www.fda.gov/ora/compliance_ref/part11/PDA-conf-sum.htm.

20. 21 CFR Part 11 Coalition public petition letter (Sept. 2004), http://www.chpa-info.org/NR/rdonlyres/.

21. Therac-25 Case Materials, http:// http://computingcases.org/case_materials/therac/therac_case_intro.html.

22. "FDA Receives a 483 on Its Birthday from Henry Waxman and His Committee," http:// http://pharmamanufacturing.wordpress.com/2006/06/28/regulators-issue-a-483-to-fda-henry-waxmans-birthday-greeting-is-of-a-whole-nother-sort/.

23. "CFSAN 2006 Program Priorities," http://www.cfsan.fda.gov/~dms/cfsan506.html.

24. Bush Budget Would Reduce Funding for FDA Safety Inspections of Foreign Drug Plants, http://www.medicalnewstoday.com/medicalnews.php?newsid=20107.

25. E. Rivera, "CDER's Guidance for Industry, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production," presented at the 14th International GMP Conference, Mar. 13–15, 2007.

26. Standish Group, 1994 Chaos Report, http://www.standishgroup.com/sample_research/chaos_1994_2.php.

27. "Diamond Nanoparticles Appear Not to Be Cytotoxic," http://www.thenanotechnologygroup.org/.

28. "Bioerodible Implants with Programmable Drug Release," http://www.sciencedirect.com/.

This article, including an online exclusion list of computer validation–related articles published in Pharmaceutical Technology, is posted on http://pharmtech.com/


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