Regulated operations
Compliance frameworks, audit trails, and quality gates tied to your artifacts.
Key outcomes
- Compliance frameworks mapped to your audit artifacts
- Quality gates and approvals enforced before release or shipment
- Verification packs generated when regulated risk changes
Solution profile
Primary teams
Quality, compliance, and regulated operations leaders
Regulatory focus
FDA 21 CFR Part 11, ISO 13485, GxP, SOX
Evidence stack
Controlled documents, approvals, validation packs
Impact Intelligence
Impact Intelligence for regulated change
Automated verification pack generation: when a change impacts regulated processes, VGE generates the validation plans, document packages, and acknowledgement tasks required by your compliance framework.
- Change-impact scoring across quality gates, SOPs, and suppliers
- Validation paths remain yours for audits
- Change approvals link directly to evidence and protocols
Engine mapping
Engines that make regulated operations audit-ready
Each engine anchors a compliance workflow with your evidence.
Engine
Quality & Compliance
Define SOPs, quality gates, validation plans, and CAPA workflows tied to evidence.
- Stop-go gates with required sign-offs
- Deviation tracking with corrective actions
- IQ/OQ/PQ-aligned validation steps
- Release readiness with required artifacts
Engine
Forensic Intelligence
Immutable event logs across materials, work orders, and documents.
- End-to-end traceability for inspections
- Exportable audit evidence per organization
Engine
Impact Intelligence (VGE)
Change-impact analysis, approval routing, and verification pack generation for regulated change.
- Approval routing with audit trails
- Acknowledgement tasks before release
- Risk scoring across quality gates and SOPs
- Evidence paths for audit submissions
Terminology
Align on the operational language.
Industry teams adopt shared definitions for assets, workflows, and compliance artifacts so every integration stays consistent.
Regulated terminology map
Shared languageControlled document
ComplianceVersioned SOPs and policies that require acknowledgement before use.
Quality gate
QualityStop-go checkpoints that block progression until evidence is approved.
Validation protocol (IQ/OQ/PQ)
ValidationStructured validation steps required for regulated process changes.
Audit pack
RegulatoryEvidence bundle of approvals, logs, and QC records for inspection.
Acknowledgement task
GovernanceRequired sign-off by regulated roles before releasing changes.
Workflow
From framework mapping to audit submission
How compliance gates, evidence, and approvals stay connected.
Step 1
Map frameworks to your evidence
Translate regulatory frameworks into controlled documents, gates, and required artifacts.
Step 2
Execute with quality gates
Run operational workflows with enforced approvals and verified evidence at each stage.
Step 3
Capture audit trails by default
Every event, approval, and exception is recorded in the provenance ledger.
Step 4
Respond to change impact
VGE triggers verification plans, acknowledgements, and release controls for changes.
Compliance
Compliance frameworks mapped to your evidence
Frameworks are configured per organization so audit artifacts stay owned, exportable, and precise.
FDA 21 CFR Part 11
Electronic records and signatures tied to immutable audit trails.
ISO 13485 / 9001
Quality management workflows with controlled documents and approvals.
GxP (GMP/GLP/GDP)
Validation controls for production, lab, and distribution workflows.
SOX + ESG
Change documentation and governance with traceable evidence.
Internal audit readiness
Audit packs and evidence exports remain yours.
Proof points
Evidence that resonates with operators.
Audit artifacts
Yours
Evidence, approvals, and logs stay within your organization.
Gate coverage
QC-first
Quality gates enforce release readiness before shipments move.
Verification packs
Generated
Regulated changes trigger pack assembly and acknowledgement tasks.
Case studies
Stories that map outcomes to industry metrics.
Embedded operations
Compliance monitoring and audit programs on the ground
Need ongoing compliance monitoring, supplier audit programs, or CAPA management for your regulated supply chain? Our embedded ops network provides ISO, FDA, and GMP audit capabilities with 15+ years in Asia.
Explore Embedded Ops