Designed for Compliance
OPUS MGL is designed to support compliance with major manufacturing quality standards. Built-in traceability, audit trails, and quality gates help streamline your compliance efforts.
OPUS MGL is designed to support compliance with these standards. Actual compliance depends on your implementation and processes.
Standards We Support
Platform features designed to help you meet regulatory requirements.
AS9100
AS9100 Rev D
Quality management system standard for aerospace industry
- Full traceability records
- Production control gate inspections
- Configuration management via BOM versioning
- Counterfeit parts tracking
IATF 16949
IATF 16949:2016
Quality management standard for automotive production
- Lot-to-product traceability
- Quality gate enforcement
- Supplier material tracking
- Process control records
FDA 21 CFR Part 11
FDA 21 CFR Part 11
Electronic records and signatures for FDA-regulated industries
- Immutable audit trails
- Role-based access controls
- PIN-based authentication
- Data integrity verification
ISO 9001
ISO 9001:2015
International quality management system standard
- Document control via checklists
- Process monitoring with SPC
- NCR and 5-Why analysis
- Continuous improvement tracking
How OPUS MGL Helps
The platform provides the data infrastructure and tracking capabilities that compliance programs require.
- Complete traceability records per serial number
- Immutable audit trail with user, timestamp, and IP
- Quality gates and checklist enforcement
- Role-based access control with 10 permission levels
- BOM version control with approval workflows
- NCR management with 5-Why root cause analysis
Compliance-Ready Features
Built into the platform
Need Help With Compliance?
Let us show you how OPUS MGL can support your specific regulatory requirements.
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