One of the first steps for any company to start to gain compliance to the FDA Final Rule of Electronic Records and Electronic Signatures (21 CFR Part 11) is to have a documented interpretation of the rule. Once the interpretation is set for the company, policies and procedures can be written according to that guidance.
This document provides a solid interpretation of 21 CFR Part 11 that allows for flexibility in designing systems around it. This document is also easily edited to your specific business requirements.
Once implemented, this interpretation can become the foundation for how to handle electronics systems that relate to GMP operations.
This interpretation document has been successfully implemented and used in over 17 companies, ranging from start-up medical device firms to large pharmaceutical corporations.