With a goal to modernize the regulation of the pharmaceutical industry, the FDA did a complete overhaul of their “Agency's Good Manufacturing Processes (GMP).” The result was the FDA regulation 21 Code of Federal Regulations (CFR) Part 11 which defines the criteria under which electronic records and electronic signatures (the validation of) are considered to be trustworthy, reliable and equivalent to paper records.

In terms of elearning this means that an LMS used by an FDA-regulated industry must fulfill the requirements set out. Some LMS vendors will claim to offer a turnkey 21 CFR “Part 11 compliant system.” This is misguided. Technology requirements are only a part of what is needed for a company to be officially compliant; there still must be a management and operational component that ensures compliance with the regulatory standards. This includes established policies and procedures that provide guidance, and control implementation details associated with the authenticity, integrity and confidentiality of electronic records, such as timesheet audit trails.

For FDA regulated companies looking into their first LMS purchase I would suggest finding a company that does not claim to be compliant. Thinking Cap offers not only the technology aspect, but also has the know how and experience to work with your team in order to ensure that your end product is fully compliant and meets the standards that the FDA has set.

To see more information on what we do to meet these requirements go to www.thinkingcap.com/21cfr