Even though FDA has relaxed some of its expectations regarding 21 CFR Part 11 compliance (see the new guideline), the rules still apply for all critical computer systems. We can help you determine how to use a risk based approach to prioritize your computer validation projects as well as write the Master Plans, protocols, and final reports required.
Step 1 of any Part 11 compliance program is to perform an assessment of your current systems to determine what is needed to bring them into compliance with FDA expectations. Our experts are current on all the latest trends. Our assessment reports are thorough and detailed with specific per system recommendations. We do not take a simple check list approach, but instead determine the aspects of the system that pose regulatory or product quality risk and how to solve those issues.