Computer System Validation Beyond GLP!
While our area of expertise is 21 CFR part 58, we have additional experience and capabilities to assist with computer system validation (21 CFR Part 11 compliance) in combination with various other predicate rules, at your request. We are able to work within the context of the regulations listed below. If you need compliance assistance with anything not listed, tell us how we can help you!
- The Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (ENV/MC/CHEM(98)17)
- GAMP 5 (Good Automated Manufacturing Practice), Guide for Validation of Automated Systems (2008)
- OECD Advisory Document No. 17, the Application of the Principles of GLPs to Computerised Systems
- EU Legislation- Eudralex Volume 4 “Good Manufacturing Practice Guidelines”, Annex 11
- The Japanese Good Laboratory Practice Standards for Safety Studies on Drugs (Ordinance No. 21 of the Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare(MHLW), Japan)
- FDA Good Clinical Practice Regulations (GCP’s) for Clinical Studies 21 CFR – part 11, 50, 54 and 56, part 312 volumes 1 & 2, Part 314 volumes 1 & 2, and Good Clinical Practice- E6(R2)
- Title 21 CFR Medical Devices Part 820 Quality System Regulation
- (IR) ICH Topic GL9(GCP) CVMP/VICH/595/98-Final
- ICH Q9 Quality Risk Management; current Step 4 version 9 November 2005
- ICH Q10 Pharmaceutical Quality System, April 2009
- Good Laboratory Practice (GLP) standards for agricultural chemicals. Agricultural Production Bureau Ref. No. 11- Nousan-No. 6283, October 1, 1999; last revised June 30, 2003 Ref. No. 15-Seisan-2460. Japan: Ministry of Agriculture, Forestry and Fisheries, Japan (MAFF).
- Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); Good Laboratory Practice standards; Final Rule; October16, 1989. U.S. Environmental Protection Agency.
- Statutory Instrument 1999 No. 3106, the Good Laboratory Practice Regulations as amended by Statutory Instrument 2004 No 994
- Statutory Instrument No 1031, the Medicines for Human User (Clinical Trails) Regulations 2004
- Statutory Instrument 2006 no 1928, The Medicines for Human Use (Clinical Trails) Amendment Regulations 2006
- Statutory Instrument 2006 No 2984, the Medicines for Human Use (Clinical Trails) Amendment (No2) Regulations 2006
- Statutory Instrument 2008 No 941, the Medicines for Human Use (Clinical Trails) and Blood and Safety Quality (Amendment) Regulations 2008