PHARMACEUTICAL VALIDATION SERVICES

Our 21 CFR Part 11 compliance checklist assessment and remediation services help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures and that those functions are in conformance with the requirements of 21 CFR Part 11 compliance. Our extensively trained professionals evaluate a client’s use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 compliance checklist and assessment determines the effectiveness of a client’s process within a highly regulated environment and suggests appropriate remedial actions as necessary.

We can give our clients an unmatched, in-depth, and thorough inspection of their systems and procedures. We ensure compliance with the requirements of 21 CFR Part 11 through our years of experience and solutions that are unique to you and your company’s needs.