21 CFR Part 11 Compliance: What Every Project Manager Needs to Know
As project managers leading IT or digital transformation efforts in regulated industries like biotech, pharma, and medical devices, we’re often tasked with more than just timelines and resource management—we’re responsible for ensuring systems support regulatory compliance from day one. One of the most critical FDA regulations we encounter is 21 CFR Part 11. Whether you're implementing an eQMS, digitizing SOPs, or managing a cloud-based data system, this rule affects how you plan, document, and validate project deliverables.