21 CFR Part 11 is the FDA regulation requiring electronic records and signatures to be as trustworthy and auditable as paper records.
Definition
21 CFR Part 11 is the US FDA regulation that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It covers audit trails, access controls, system validation, and the integrity of electronic signatures. Any MES, LIMS, or DCS operating in an FDA-regulated facility must comply with it.
What this means when you're hiring
I ask about Part 11 in almost every MES interview I conduct for pharma clients. It tells me immediately whether a candidate has worked in a real GMP environment or just claims to have done so. Candidates who understand audit trails, user access management, and electronic signature workflows are far more deployable into regulated sites. It's a shortcut to assessing genuine regulatory experience.
Where candidates get this wrong
Part 11 is frequently treated as a checkbox exercise , 'we have audit trails, we're compliant.' The FDA doesn't see it that way. Compliant audit trails must be computer-generated, time-stamped, secure, and attributable to the individual who created or modified a record. A system with configurable audit trails that users can edit is non-compliant, regardless of what the vendor claims.
How expectations change by level
Junior engineers need to know Part 11 exists and what it requires from a configuration standpoint. Mid-level engineers should be able to configure and validate Part 11-compliant systems. Senior engineers and consultants are expected to own the compliance posture, conduct risk assessments, and engage directly with QA and regulators on Part 11 findings.
Related Platforms
Related Roles
Ready to hire in MES or Industry 4.0?
We specialise exclusively in manufacturing software and digital transformation leadership. 250+ critical hires delivered.