FDA Compliance Software
Manufacturing software built for FDA 21 CFR Part 11 compliance. Electronic records, electronic signatures, audit trails, and access controls — without bolted-on point solutions.
When an FDA investigator asks who released lot 2024-0847, quality engineers should pull one screen in seconds. WorkCell runs 21 CFR Part 11 as native ERP behavior: electronic DHRs, re-authenticated signatures, tamper-evident audit trails, and role-based access enforced at the database.
Paper batch records nobody can find
Paper DHRs meet the letter of FDA 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 FDA data integrity guidance expectations around who changed what and when go unmet on the records that matter.
E-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 the floor for an hour.
Electronic batch records
Every work order is an electronic DHR with material lots, equipment IDs, operator IDs, in-process checks, and deviations captured as structured data mapped to fda 21 cfr part 820 requirements.
Electronic signatures with full traceability
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.
Tamper-evident audit trails
Every create, update, and delete on a regulated record is logged with user, timestamp, old value, new value, and reason for change, matching FDA data integrity guidance and unavailable for edit by users, admins, or the vendor.
Validation support and change control
IQ, OQ, and PQ templates ship with the system along with a traceability matrix aligned to FDA process validation guidance, so patching doesn't mean re-validating the whole stack.
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 DHR.
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 and who does it apply to?
21 CFR Part 11 defines when electronic records and signatures are trustworthy enough to replace paper. It applies to anyone creating FDA-required records electronically, including device makers under fda 21 cfr part 820, drug makers under Part 211, and biologics under Part 600.
Does using WorkCell satisfy FDA requirements on its own?
WorkCell provides the technical controls Part 11 requires, including 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.
What does validation look like for a Part 11 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 traceability matrix so your team starts with system-level tests already written.
FDA Compliance Software
Turn your next FDA inspection into a one-screen answer.