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ISO 9001. AS9100 Rev D. IATF 16949.
Evidence collected automatically.

ForgeCompliance covers six regulatory frameworks — ISO 9001, AS9100 Rev D, IATF 16949, FDA 21 CFR Part 11, ITAR, and CMMC 2.0. Evidence is collected automatically from ForgeCAD, ForgeMachine, ForgeMaint, and ForgeProcure. Document control, nonconformance tracking, CAPA workflows, internal audit scheduling, and supplier qualification — all in one place.

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ISO 9001AS9100IATF 1694921 CFR 11ITARCMMC 2.0

Why ForgeCompliance is different

"Evidence collection is automated — not a manual exercise every time an auditor asks."

ForgeCompliance subscribes to events from ForgeCAD, ForgeMachine, ForgeMaint, and ForgeProcure via ForgeHub. Every design record, production record, PM record, and supplier record is captured automatically as evidence against the applicable clause. When the ISO 9001 auditor asks for calibration records, ForgeCompliance has already collected them.

"ForgeCompliance covers six distinct regulatory frameworks — not one generic quality module."

ISO 9001:2015, AS9100 Rev D, IATF 16949:2016, FDA 21 CFR Part 11, ITAR, and CMMC 2.0. Each framework has its own clause tree, its own evidence mapping, and its own document control requirements. A document required by AS9100 clause 8.5.6 is not the same document required by FDA 21 CFR Part 11 §11.10 — ForgeCompliance maintains both separately.

"Nonconformance tracking with CAPA workflows — not a spreadsheet with a status column."

A nonconformance record captures: detected by, detection method, affected part or process, disposition, root cause analysis (5 Why or Ishikawa), corrective action, preventive action, effectiveness check date. CAPA is linked to the original nonconformance. Closure requires all fields complete and effectiveness check passed. ForgeKnowledge captures the full decision trail.

From evidence collection to audit-ready

ForgeCompliance collects evidence continuously so audits are not a fire drill.

1

Map Clauses

Manual

Configure which regulatory frameworks apply to your facility. ForgeCompliance loads the clause tree for each framework and maps evidence types to clauses.

2

Collect Evidence

Automated

ForgeCompliance subscribes to ForgeCAD design records, ForgeMachine production records, ForgeMaint PM records, and ForgeProcure supplier records. Evidence is captured automatically as it is produced.

3

Control Documents

Manual

Controlled documents are authored, reviewed, approved, and distributed in ForgeCompliance. Revision history is maintained. Superseded versions are archived. Distribution is tracked.

4

Track Nonconformances

Manual

Open a nonconformance record when a product, process, or supplier fails to meet a requirement. Assign disposition, root cause analysis, corrective action, and effectiveness check date.

5

Audit and Close

Manual

Schedule internal audits. Collect findings. Link findings to corrective actions. Audit evidence package is compiled automatically from ForgeCompliance records for external auditors.

Every capability, in depth

Six Regulatory Frameworks

ISO 9001, AS9100 Rev D, IATF 16949, FDA 21 CFR Part 11, ITAR, CMMC 2.0. Each has its own clause tree and evidence mapping — not a single generic quality module.

Automated Evidence Collection

Design records from ForgeCAD, production records from ForgeMachine, PM records from ForgeMaint, supplier records from ForgeProcure — collected automatically against clauses.

Nonconformance and CAPA

Root cause (5 Why or Ishikawa), corrective action, preventive action, effectiveness check. CAPA linked to the original nonconformance. Closure requires all fields complete.

Document Control

Revision, review, approval, distribution, and archive — with electronic signatures compliant with FDA 21 CFR Part 11 §11.10. Superseded versions are archived, never deleted.

Supplier Qualification

Qualification records, ongoing monitoring, incoming inspection results, deviation and waiver management. Linked to approved vendor list in ForgeProcure. AS9100 Rev D clause 8.4.1 compliance.

6

Regulatory frameworks

ISO 9001, AS9100, IATF 16949, FDA 21 CFR Part 11, ITAR, CMMC 2.0

Automated

Evidence collection

Subscribes to all Forge product events

CAPA

Nonconformance workflow

Root cause, corrective, preventive, effectiveness check

Clause-mapped

Document control

Every document linked to the clause it satisfies

Integrations

Receives from

ForgeCADDesign records
ForgeMachineProduction records
ForgeMaintPM records
ForgeProcureSupplier records

Sends to

ForgeKnowledgeAudit evidence and decision records

Six frameworks. Evidence collected automatically. Audits without fire drills.

ForgeCompliance is not a generic quality module with a configurable field list. It is clause-mapped compliance infrastructure for the frameworks that aerospace, automotive, defense, and medical manufacturers actually operate under.

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