Computer System Validation

The cGMP Compliance Group validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA and other regulatory agencies. Our consultants have extensive experience in the pharmaceutical, biotech, medical device, and software industries.

Compliance with FDA 21 CFR 11 Electronic Records; Electronic Signatures and EU Annex II Computerized Systems is a must in our industry. If your organization's growth depends on compliance with Part 11 or Annex 11, The cGMP Compliance Group has the experts you need to get your systems, procedures, validation documents ready.