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