Workshop on 21 CFR PART 11

Although 21 CFR Part 11 has been in place for eight years and enforced for six years, companies are still confused about how to implement it. FDA requested Part 11 compliance for all such records that were generated or stored on a computer and could ask for such records at inspections.

With this very broad interpretation, full implementation was very expensive and for some applications, it was impractical. In some cases, companies decided to keep paper records because of the anticipated additional complexity and cost involved with implementing the technical control required by the rule. This outcome clearly was not the original intent and spirit of the rule which was issued to protect public health and enable new technology to be used.

This rule requires software for document encryption and may also require hardware and software for generating digital signatures.

In this program we will provide guidelines on how to implement 21 CFR Part 11.