Approach21 CFR Part 11

In 1997, the Food and Drug Administration (FDA) issued regulations that provide criteria for acceptance by FDA of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

CFR 21 Part 11, rather than being an imposition, can be regarded as an opportunity for SOLABS' GxP customers to diminish the complexity linked with the management of their documentation. Indeed, electronically-generated documentation can bring considerable resource savings.

The treatment of CFR 21 Part 11 must be in a clear and consistent manner and SOLABS has considerable experience in implementing installations of procedures that are fully compliant.