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/
|
