Within todays regulatory / political environment, our global company
is dealing with more and more regulations that impact computerized
As an exercise, we started to list all the regs that
impact computer systems within our manufacturing, R&D, and business
Some directly, others indirectly. This goes beyond FDA.
This is our list.
I am hoping that this group will add other regs
to the list below that impact their companies.
I think it will be very interesting to compile a thorough list.
- FDA GLP
- FDA GCPs
- FDA cGMPs
- FDA Part 11
- FDA Guidance on computerized systems in clinical trials
- SOX (US)
- HIPAA (US)
- Pedigree (US)
- GMPs of specific countries (Japan, Canada, Australia,....)
- EU Data Protection - DIRECTIVE 95/46/EC
- EU GMPs: Annex 11 and 15