Solution Page for FDA Title 21 CFR Part 11 in GitLab
Briefly describe the update
Add a solution page to describe GitLab Best Practices and Features for customer's wanting to comply with FDA Title 21 Part 11
There is a good document put together by @jrandazzo that covers GitLab Best Practices that lives in a Google Doc (GitLab Internal) that should be made public so Everyone Can Contribute.
WHAT IS 21 CFR PART 11?
21 CFR Part 11 is the FDA's regulations for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company’s quality management system.
Since 21 CFR Part 11 was first published in 1997, our electronic systems and their capabilities have advanced tremendously. However, the purpose of 21 CFR Part 11 still remains applicable over two decades later.
Part 11 was designed to cater to the evolving needs of the medical device industry, with the purpose of helping companies:
Know how to use computer systems and software, particularly when it isn’t working properly. Maintain data safely and securely, and ensure data is not corrupted or lost. Ensure that approval and review signatures cannot be disputed. Trace changes to data Prevent and/or detect falsified records We have also had to be more practical about how paperwork is managed across organizations that may have multiple offices or multiple people that need to access and update records. Using a paper-based system in a single office is challenging, and with offices based around the globe, it’s simply not practical.
With electronic records becoming widely used in the industry, the vast majority of companies will find that FDA 21 CFR Part 11 applies to them. As with many regulations, this isn’t always received well.
Many companies find the prospect of validating for 21 CFR Part 11 daunting. It’s necessary to prove to regulators that your system is robust enough to meet their standards, and this can be a challenge.
For example, there are a number of companies that are somewhat apprehensive of 21 CFR Part 11 because of the things needed to prove a system is robust enough to meet its standards.