21 CFR Part 11 and EU Annex 11 Computerized Systems Audits:

20 plus years of hands-on computerized system auditing and computer system validation regulated industry experience – Call Us Today!
Conducting 21 CFR Part 11 and EU Annex 11 computerized Systems Audits is a very important and challenging activity for Pharmaceutical Drug, Medical Device, Biotechnology and Healthcare Supplier companies. To be effective, it requires direct applicable knowledge and hands-on industry auditing experience with regulatory requirements for computerized systems, computer system validation life cycle industry experience and knowledge, and the ability to assess internal quality system requirements to determine the adequacy and effectiveness of the Quality Management System against regulatory or international requirements.

The Quality of our auditing services are best in class meaning we provide more benefits and value-added services for less money!
We provide high-caliber, FDA Compliance Specialists with 15+ years of regulated industry auditing experience; we provide a cost-effective, fixed price audit for each audit we support; our fixed price audit includes: pre-audit preparation; audit planning; travel time (U.S. only); the audit itself; daily audit debriefs; the final audit report with one review cycle; and we assign a dedicated U.S. based audit administrator for every audit we support.

FREE FDA Compliance Training $10,000 Value!
For each new Pharmaceutical, Medical Device, Biotechnology, and Healthcare Supplier client - After we support three (3) audits on your behalf, we will provide our most popular “21 CFR Part 11 & FDA Auditing of Computerized Systems” online training class for up to 5 employees for FREE ($10,000 value)!

Global GxP Drug and Medical Device Supplier Quality Audits