FDA Validation and Compliance
To promote business continuity and compliance with regulatory guidelines, we offer a comprehensive line of validation, compliance, and quality services to clients. Our team of subject matter experts is well versed on the most up-to-date guidance from the FDA and can bring a practical understanding of interpretations required to mitigate risk enterprise-wide.
Capabilities cover the full range: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, Part 58, and across the entire spectrum: CSV, GMP, GLP, GCP, GDP, GxP, ICH, CQV, equipment/utilities/facilities, process/cleaning/packaging.
Engineering design qualification services include:
- Design qualification
- Conducting vendor audits, FAT (factory acceptance testing), and SAT (site acceptance testing)
- Software developer assessment
- Specifications – user requirements, functional requirements, and detailed design
For more information, contact: