21 CFR Part 11 Compliance Software
Support FDA 21 CFR Part 11 electronic records and signatures with audit trails, role-based access, bound e-signatures, and lot and serial traceability.
FDA 21 CFR Part 11 is the U.S. Food and Drug Administration regulation that defines when electronic records and electronic signatures are trustworthy enough to be treated as equivalent to paper and handwritten signatures. It matters because if you make FDA-regulated products (drugs, biologics, medical devices, food, cosmetics) and keep batch records, device history records, or quality data electronically, those records are only acceptable to the FDA when the system enforces Part 11 controls like audit trails, access limits, and signature binding. WorkCell is not certified to Part 11 (no software is, since compliance is a property of the validated system plus your procedures), but its audit trail, role-based access, electronic signature, and lot/serial traceability features give you the technical controls a Part 11 program depends on.
Sound Familiar?
Spreadsheet batch records the FDA won't accept
Your device history records and batch production records live in Excel and shared drives where anyone can overwrite a cell, no audit trail captures who changed what, and an FDA investigator can flag the entire records system as failing 21 CFR Part 11 because the data has no integrity controls.
Signatures that aren't actually bound to the record
Operators initial a paper traveler or paste a name into a PDF, but nothing links that approval to the specific record version, the signer's identity, the date and time, and the meaning of the signature, which is exactly the binding Part 11 section 11.50 and 11.70 require before an electronic signature counts.
Audit trails that can be turned off or edited
Data integrity findings (the ALCOA+ failures behind most FDA 483s and warning letters) come from systems where audit trails are optional, deletable, or absent, so you cannot reconstruct who created, modified, or deleted a GMP record or prove the record is attributable, contemporaneous, and original.
Access controls that don't separate duties
Shared logins on the shop floor, no segregation between the operator who runs a step and the quality reviewer who releases it, and no way to limit which roles can approve a deviation mean you can't demonstrate the authority checks Part 11 section 11.10 demands during an inspection.
Core Capabilities
Computer-generated, time-stamped audit trails
Every create, update, and delete on regulated records (work orders, inspections, lots, BOM and routing revisions) is captured with the user, timestamp, and before and after values, supporting the secure, computer-generated audit trail that 21 CFR Part 11 section 11.10(e) and ALCOA+ data integrity expectations require.
Role-based access and segregation of duties
Granular roles and permissions limit system access to authorized individuals and separate the operator who executes a step from the quality role that reviews and releases it, giving you the authority checks and access limits described in Part 11 section 11.10(d) and (g).
Electronic signatures bound to the record
Review and release transitions capture the signer, the date and time, and the meaning of the signature (such as authored, reviewed, or approved), bound to the exact record version so the signature cannot be copied, cut, or transferred, in line with Part 11 sections 11.50 and 11.70.
End-to-end lot and serial traceability
Lot and serial genealogy with QC hold states and multi-location zones tracks material from receipt through work orders to lot-linked shipment, so your electronic batch record and device history record reconstruct the full as-built history the FDA expects to be original and attributable.
Quality records with NCR, CAPA, and inspections
AQL inspection templates, multi-type inspections, the NCR severity matrix, and 8-D CAPA keep deviations, nonconformances, and corrective actions as controlled electronic records with their own audit trails and signature steps, instead of paper forms an investigator can't trust.
Engineering change control via versioning
Multi-level versioned BOMs and routings with effective dating provide engineering change control, so each manufactured lot is locked to the exact BOM and routing revision in effect when it ran and that history stays queryable for an audit.
By The Numbers
The FDA regulation establishing criteria for electronic records and electronic signatures to be trustworthy and equivalent to paper, in effect since 1997
U.S. FDA, Code of Federal Regulations Title 21 Part 11
The FDA and MHRA data integrity principles that records be Attributable, Legible, Contemporaneous, Original, and Accurate (plus Complete, Consistent, Enduring, Available)
FDA Data Integrity and Compliance With Drug CGMP Guidance
Data integrity and records control deficiencies are consistently among the most cited observations in FDA drug GMP inspection 483s each fiscal year
FDA Inspection Observations (Form 483) Datasets
Connected Modules
Quality
Inspections, NCRs, and CAPAs are controlled electronic records with audit trails and signature steps, so deviations and dispositions are attributable and reconstructable for the FDA.
Shop Floor
Operator and terminal MES execution captures who ran each operation and when, with review and release signatures bound to the work order and lot.
Engineering
Versioned BOMs and routings with effective dating provide change control, locking each lot to the exact revision in effect when it was built.
Common Questions
What is 21 CFR Part 11?
21 CFR Part 11 is the FDA regulation in Title 21 of the Code of Federal Regulations that sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to records that FDA-regulated companies create, modify, maintain, or submit electronically in place of paper, and it requires controls such as audit trails, system validation, access limits, and signature binding.
Who has to comply with 21 CFR Part 11?
Any organization regulated by the FDA that keeps required records or signatures electronically must comply, including pharmaceutical and biologics manufacturers, medical device companies, contract manufacturers, and many food, dietary supplement, and cosmetics firms. If you choose to keep batch records, device history records, or quality data on paper, Part 11 does not apply to those records, but the moment you maintain or submit them electronically the controls become mandatory.
Can software be 21 CFR Part 11 certified?
No. The FDA does not certify software for Part 11, and compliance is never a property of the software alone. It is a property of the validated system in your environment combined with your standard operating procedures, training, and controls. A vendor can provide the technical features that make compliance achievable (audit trails, access control, electronic signatures), but you still validate the system and operate it under documented procedures. WorkCell provides those supporting features but does not hold a Part 11 certification.
How does WorkCell support 21 CFR Part 11 compliance?
WorkCell provides the technical controls a Part 11 program relies on: computer-generated, time-stamped audit trails on regulated records, role-based access with segregation of duties, electronic signatures bound to the specific record version with signer identity, timestamp, and meaning, and end-to-end lot and serial traceability for electronic batch and device history records. You pair those features with your own validation and procedures to operate a compliant system.
What is the difference between 21 CFR Part 11 and ALCOA+?
Part 11 is the binding regulation that defines acceptable electronic records and signatures, while ALCOA+ is the set of data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) the FDA uses to evaluate whether records meet good documentation practices. Part 11 controls like audit trails and signature binding are how you demonstrate ALCOA+ in an electronic system.
What does an FDA investigator look for in an electronic records system?
Investigators look for secure, computer-generated audit trails that cannot be disabled or edited, access controls that limit and segregate who can perform and approve actions, electronic signatures linked to the right record and signer, evidence that the system was validated for its intended use, and the ability to reconstruct the full history of a batch or device. Records that fail these checks commonly appear as data integrity observations on FDA Form 483s and warning letters.
Does WorkCell handle electronic batch records and device history records?
Yes. WorkCell builds the electronic batch record and device history record from the same data the shop floor runs against: lot and serial genealogy, work order execution with operation-level signatures, QC inspections and dispositions, and lot-linked shipments. Because each lot is tied to the exact versioned BOM and routing in effect when it ran, the as-built history stays original, attributable, and queryable for an audit.
21 CFR Part 11 Compliance Software
Build FDA-ready electronic records on controls you can actually defend in an audit.