21 CFR Part 11 Compliance: Validation Assistance

Last revised: 

More information and assistance validating your system is available through CTSI Consultation Services. A validation expert is available to help you plan and carry out the necessary activities and documentation needed to satisfy sponsor audits and FDA inspections.

Services include:

  • Part 11 planning and guidance
  • Creating system documentation templates
  • SOP and user manual development and review
  • Technical document development and review
  • Verification protocol development and review
  • System testing design and conduct
  • Validation certification development and review
  • Sponsor audit and FDA inspection preparation, support, and corrective action follow-up