Computer System Validation Auditing

FormaliS conducts audits of computer systems tocheck compliance with regulations and appropriate validation.

Activity:

Auditing Computer Systems for:

  • Validation
  • Security
  • Stability
  • Suitability
  • Regulatory Compliance

Scope:

Computer Systems in:

  • Clinical Research
  • Data Management
  • Analytical Labs
  • Pre-Clinical Research
  • Automated Systems in Production Devices

Standards:

  • 21 CFR
  • Computerized Systems in Clinical Trials
  • GAMP standard and applicable regulations