Complete listing of regulations

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Hi All,

Within todays regulatory / political environment, our global company
is dealing with more and more regulations that impact computerized
systems.

As an exercise, we started to list all the regs that
impact computer systems within our manufacturing, R&D, and business
areas.

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
2

A few others more security related, not really applicable to most pharma
companies:

  • GLBA (Gramm-Leach-Bliley Act)
  • FACTA (Fair and Accurate Credit Transaction Act)
  • US Patriot Act
  • State Data Protection Laws
  • E-Discovery (Electronic Discovery in Federal Rules of Civil Procedure)
  • PCI Standards (Payment Card Industry)
3

Hi
GAMP 4 (Good Automated maufacturing process)

A must guideline for software validation used for Manufacturing process automation.