FDA 21 CFR Part 11 Compliance Software
FDA compliance software for 21 CFR Part 11 and 21 CFR 820 — electronic records, signatures, audit trails, and batch records native to your ERP.
21 CFR Part 11 compliance shouldn't mean three bolted-on systems and a shelf of paper binders. WorkCell runs the Code of Federal Regulations 21 CFR Part 11 as native ERP behavior: electronic batch records, re-authenticated electronic signatures, tamper-evident audit trails, and role-based access aligned to 21 CFR Part 820 and cGMP expectations.
Paper batch records nobody can find
Paper batch records and device history records meet the letter of 21 CFR Part 820 and fail every audit, retrieval, and complaint investigation that happens after the lot ships.
Audit trail gaps investigators will find
Your MES, QMS, and ERP each log fragments, so 21 CFR Part 11 expectations around who changed what, when, and why go unmet on exactly the electronic records that matter.
Electronic signature workarounds that don't hold up
Shared logins, pre-signed forms, and sticky-note passwords turn into 483 observations the moment an investigator watches your floor for an hour.
Validation debt that blocks every release
Every small change kicks off a full computer system validation cycle because there's no traceability between requirements, tests, and the controls 21 CFR Part 11 actually requires.
Electronic batch records
Every work order is an electronic batch record and device history record with material lots, equipment IDs, operator IDs, in-process checks, and deviations captured as structured data mapped to 21 CFR Part 820 requirements.
Part 11 electronic signatures
Every signing event captures unique identity, meaning, timestamp, and exact record version, with re-authentication required and the signature manifest included in any human-readable copy, matching 21 CFR Part 11 Subpart C.
Tamper-evident audit trails
Every create, update, and delete on a regulated electronic record is logged with user, timestamp, old value, new value, and reason for change — unavailable for edit by users, admins, or the vendor.
Access control and account management
Role-based permissions, unique user IDs, automatic session timeout, and separation of duties close the access-control gaps that Part 11 Subpart B and cGMP inspectors look for first.
Record retention and legible copies
Regulated records stay retrievable for the full retention period with accurate, human-readable exports and complete audit-trail history on every lot, device, and signature.
Validation and change control
IQ, OQ, and PQ templates ship with the system alongside a traceability matrix aligned to FDA process validation guidance, so computer system validation doesn't restart with every patch.
Form 483 observations issued by FDA in fiscal year 2023 across device, drug, and food facilities
FDA Inspection Observations Dataset
Consent decree penalty paid by a single pharma manufacturer for cGMP and data integrity failures
U.S. Department of Justice
Average cost of a medical device recall, with data integrity and record-keeping failures among the leading causes
Stericycle Recall Index
Quality
Nonconformances, CAPAs, and inspection records live as electronic records with Part 11 signatures and audit trails tied to the lot they affect.
Shop Floor
Operators sign into authenticated sessions so every production event, in-process check, and material consumption becomes part of the electronic batch record.
Inventory
Lot and serial genealogy ties raw materials to finished goods with full forward and backward traceability, so a recall resolves in minutes.
What is 21 CFR Part 11?
21 CFR Part 11 is the section of the Code of Federal Regulations that defines when electronic records and electronic signatures are trustworthy enough to replace paper for FDA-regulated activities. It sets requirements for audit trails, access controls, system validation, and the signing process itself.
Who does 21 CFR Part 11 apply to?
Part 11 applies to anyone creating, modifying, or transmitting FDA-required records electronically — device makers under 21 CFR Part 820, drug makers under 21 CFR Parts 210 and 211, biologics manufacturers, and contract organizations acting on their behalf.
What does 21 CFR Part 820 require?
21 CFR Part 820 is the FDA's Quality System Regulation for medical device manufacturers. It requires design controls, document control, device history records, CAPA, supplier controls, and complaint handling — and pairs with Part 11 whenever any of those records are kept electronically.
What is cGMP and how does it relate to Part 11?
cGMP stands for current good manufacturing practice — the FDA's baseline expectations for drug, biologic, and device production under 21 CFR Parts 210, 211, and 820. Part 11 is how cGMP records are kept when they live in software instead of on paper.
What counts as an electronic record under Part 11?
An electronic record is any combination of text, graphics, data, or audio created, modified, or maintained in digital form that's required by an FDA predicate rule. That covers batch records, device history records, CAPAs, audit logs, and electronic signature manifests tied to them.
What makes an electronic signature Part 11 compliant?
A Part 11 electronic signature has to be uniquely linked to one individual, require re-authentication for each signing event, capture the printed name, timestamp, and meaning of the signature, and appear on any human-readable copy of the record alongside the record itself.
How do electronic batch records work?
An electronic batch record replaces the paper master batch record with a structured, versioned document that captures every material lot, equipment ID, parameter, deviation, and signature in real time. Reviewers query by exception instead of flipping pages, and the full device history record is retrievable in seconds.
What is computer system validation for a Part 11 system?
Computer system validation follows a V-model with user requirements, functional specs, IQ, OQ, and PQ aligned to FDA process validation guidance. WorkCell ships baseline IQ and OQ templates and a requirements-to-test traceability matrix so your team starts with system-level tests already written.
Does using WorkCell make us FDA compliant?
WorkCell provides the technical controls 21 CFR Part 11 requires — electronic records, signatures, audit trails, and access controls. You still own the SOPs, training, and validation package that turn those controls into a compliant quality system the FDA will accept.
FDA 21 CFR Part 11 Compliance Software
Turn your next FDA inspection into a one-screen answer under 21 CFR Part 11.