The characteristic increases in efficiency as a result of transitioning to a streamlined paperless operation are of little value if the transformed organization fails to be 21 CFR Part 11 compliant. It’s critical every step to paperless transformation is guided by professionals who are skilled in the requirements for compliance.
For many research organizations, the incoming stream of regulatory documents that require printing, routing, signing, and filing is never-ending. But many have not yet made the transition to electronic documents and signatures. In this post, we explore how to transition to an electronic regulatory (eRegulatory) solution.