Support for Validation Professionals

Has this ever happened to you? You've been asked to validate one of your internal databases, and it has almost none of the controls required by 21 CFR Part 11. To make matters worse, you know that there is little or no security on the program, and you were even able to open the program and make changes to the database itself. Clearly this is not a validatable system! What do you do?

We can help. In as little as 8 hours, we can implement all the technical requirements required by Part 11, all without changing how the original program works (so you won't have to re-write your specifications!). We will even provide a full Gap Analysis report that explains how the system now meets the technical requirements of Part 11, including a Corrective Action Plan that details the procedural tasks that will need to be covered outside of the program (SOPs, policies, etc).