- 21 CFR Part 11 sets the FDA's rules for trustworthy electronic records and signatures - audit trails, access controls, and attributable, unalterable records.
- Compliance is really about data integrity (ALCOA): records must be attributable, legible, contemporaneous, original, and accurate.
- Digitizing GMP records compliantly means enforcing these properties by design - not bolting a signature onto a PDF.
If you make pharmaceuticals, medical devices, or other FDA-regulated products and you want to move records off paper, 21 CFR Part 11 is the regulation that governs how. It defines when electronic records and signatures can be trusted like paper ones. It is often treated as intimidating; in practice it comes down to a few clear principles. This is a plain-English primer.
What Part 11 requires, in plain terms
- Validated systems - the software does what it's supposed to, reliably.
- Secure, attributable records - tied to identified users, protected from unauthorized change.
- Computer-generated audit trails - time-stamped records of who did what, including changes, that cannot be silently altered.
- Access and authority controls - only authorized people can perform a given action.
- Electronic signatures - linked to their records and to a specific, identified person.
It is really about data integrity
Underneath the clauses, Part 11 is about data integrity, captured by ALCOA: records must be Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+ adds Complete, Consistent, Enduring, Available). If your electronic records have those properties, you are most of the way to Part 11; if they don't, no amount of process papers over it.
A common mistake is treating Part 11 as “add an e-signature to the document.” But a signed PDF that can be edited, has no audit trail, and isn't tied to a validated, access-controlled system fails the intent entirely. Compliance comes from records that are attributable and tamper-evident by design - not from a signature graphic.
Digitizing records compliantly
The reliable path is to run records as executable workflows in a system that enforces the principles: every entry attributed and time-stamped, values captured contemporaneously at the point of action, changes logged in an immutable audit trail, access controlled by role, and signatures bound to records and identities. Done this way, ALCOA is satisfied by construction, and Part 11 readiness follows from how the system works rather than from extra paperwork.
RakuOps captures records contemporaneously with attributed, time-stamped entries and a tamper-evident audit log, with role-based access - the data-integrity foundation that underpins 21 CFR Part 11. (As with any regulated deployment, the system is validated for your specific use.)