Manufacturing Compliance Software, Built Into the OS
AS9100, FDA 21 CFR Part 11, and ITAR controls as core platform features — not a separate QMS you later reconcile with your ERP.
Auditors don't care that your QMS and ERP are different systems.
They ask for a signed revision of a work instruction tied to the operator who ran the job on the serial that failed in the field. If that trail lives across four tools — QMS, ERP, file share, and paper travelers — you don't have traceability. You have a scavenger hunt.
Every regulated shop we talk to has the same three scars.
Document pulled from the wrong folder
An operator ran Rev C while Rev D was released three weeks ago. The revision lived in the QMS. The traveler came from the ERP. Nothing stopped the mismatch.
CAPA without a traceable root
A customer return surfaces on serial 4812. You can't link it to a heat lot, to a specific machine run, to the inspector who signed it off. The corrective action writes itself around the gap.
E-signatures on paper
Final inspection gets signed in ink, scanned, filed, and forgotten. The e-signature requirement never actually got implemented — it got photocopied.
AS9100, FDA Part 11, and ITAR demand mostly the same software.
Auditors from three different worlds ask for the same six things, wearing different vocabulary. A serialized aerospace assembly and a Class II device need identical record-keeping primitives — attributable signatures, immutable logs, controlled documents, qualified operators, restricted access, and controlled data locations. Aerospace calls it configuration management; life sciences calls it document control; defense calls it technical data segregation. The underlying software primitive is the same.
Treat them as one set of platform controls and the per-standard audits become configuration questions, not re-implementations. Enable a control once, scope it to the records a given standard covers, and let the audit trail prove the rest.
That's the wedge: the vendors at the top of this SERP sell a QMS and a GRC tool. They solve compliance as a document problem. Manufacturing compliance is a record problem — and the records are jobs, serials, lots, operators, and routings, not PDFs.
Identity-bound sign-offs on records, approvals, and releases.
Immutable who/what/when on every record change across modules.
Controlled drawings, SOPs, specs, and work instructions with approval workflow.
Operator qualification tied to routings, work orders, and sign-offs.
Role-based permissions, SSO, and least-privilege by module and record.
Controlled storage region, backups, and export for regulated data.
AS9100 / Aerospace & Defense
If you supply aerospace primes, tier-1 integrators, or defense OEMs.
AS9100 extends ISO 9001 with aerospace-specific requirements: configuration management, risk-based CAPA, FAIR reporting, counterfeit parts prevention, and full lot/serial traceability from raw bar to shipped assembly.
- ›Configuration management on every revision
- ›First Article Inspection (AS9102) support
- ›Lot and serial traceability end-to-end
FDA 21 CFR Part 11 / Life Sciences
If you make medical devices, pharmaceuticals, or regulated food and beverage.
Part 11 governs electronic records and electronic signatures for anything the FDA might inspect. Device History Records, batch records, validation documentation, and e-signatures must be attributable, legible, contemporaneous, original, and accurate.
- ›21 CFR Part 11 compliant e-records and e-signatures
- ›DHR, MDR, and batch record generation
- ›Validation-friendly change control and audit exports
ITAR / Defense Export Controls
If you handle technical data for USML articles or hold DDTC registration.
ITAR requires that technical data stays with US persons and inside US-only infrastructure. That means not just hosting region, but every backup, log, support session, and AI inference path staying in bounds.
- ›US-only data residency, backups, and support
- ›US-persons access enforcement and attestations
- ›Technical data marking, segregation, and export logs
A QMS bolted onto an ERP is two systems and one audit finding.
The industry default is to buy an ERP for work orders, inventory, and schedule, then buy a separate QMS for documents, CAPAs, and training — and hire an integrator to wire them together. It works on a slide. It falls apart when a record exists in one system and the object it describes lives in another. Nonconformance opens in QMS, the work order lives in ERP, the drawing lives in the vault, the operator lives in HR. The auditor asks one question and you open four tabs.
WorkCell is a manufacturing OS where the compliance primitives — e-signatures, audit trails, revision control, training-gated routings, RBAC, and controlled data residency — are the same objects the shop floor uses. Sign a router and you've signed a record. Release a drawing and every open work order for it sees the change. Qualify an operator and they appear on the routings they're allowed to run. Reject a part and the CAPA links to the serial, the lot, the machine, the inspector, and the revision automatically — because they were already the same record.
You don't reconcile. The data was never in two places. And because the platform ships with SOC 2 Type II, role-based access, SSO, and a controlled-residency option, the foundational controls your auditor asks about are already on.
That's why a shop running WorkCell can layer AS9100 for the aerospace line, Part 11 for a medical contract, and ITAR for a defense program without stacking three systems. One platform, one audit trail, scoped by record.
One schema. One audit log. Every module inherits the same compliance primitives — which is why adding AS9100, Part 11, or ITAR is a configuration, not a second purchase order.
See Your Audit Trail, From Quote to Ship.
Walk through AS9100, FDA Part 11, and ITAR controls on a real WorkCell tenant. 30 minutes, your questions, no slides.