Ensuring Compliance with 21 CFR 11

Suppose you have an Access database that helps your department. Maybe it generates a monthly tracking report or tracks an important process. Unfortunately, your Quality group, which is tasked with ensuring compliance, has just reviewed your department and alerted you that this database has almost none of the controls required by 21 CFR Part 11. To make matters worse, you know 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. What do you do?

Ofni Systems can help. We can implement all the technical requirements of 21 CFR Part 11 without changing how your original MS Access program works (you won’t have to change your practices or rewrite your procedures!). We will even provide a full gap analysis report explaining how the system now meets Part 11 technical requirements, including a Corrective Action Plan detailing required procedural tasks external to the program (SOPs, policies, etc.). Ofni Systems also has tools to rapidly document and test MS Access files, allowing us to validate your database quickly and efficiently.

More information about the Part 11 Toolkit