Compliance by design
Compliance isn't a checkbox. It's the architecture. Every design decision in MESvantage was made with ISO 13485 and FDA 21 CFR Part 11 in mind from the first line of code.
21 CFR Part 11
The FDA's electronic records and electronic signatures regulation requires that any software used in regulated manufacturing maintains trustworthy, reliable, and generally equivalent records to paper.
MESvantage has passed IQ/OQ/PQ validation under Part 11 in a live high-volume orthopaedic production environment. The validation documentation package is transferable to new customer deployments.
- ✓ Immutable audit trail on every record change
- ✓ Electronic signatures with identity verification
- ✓ Role-based access controls with least-privilege enforcement
- ✓ Closed system with access limited to authorised users
- ✓ System-generated, computer-readable audit trails
- ✓ Date/time stamping on all record modifications
- ✓ Sequence of events with operator identification
- ✓ Validation documentation package (IQ/OQ/PQ)
ISO 13485
ISO 13485 is the quality management standard for medical device manufacturers. MESvantage's quality module directly supports the traceability, DHR, and process control requirements auditors look for.
- ✓ Digital Device History Record (DHR)
- ✓ Full component and process traceability
- ✓ Incoming inspection with accept/reject workflow
- ✓ First Article Inspection (FAI) records
- ✓ Non-conformance tracking and CAPA linkage
- ✓ Customer-facing quality portal
- ✓ Training records linked to operator access
- ✓ Process control with SPC alerting
Siloed SaaS
Each MESvantage customer receives a fully isolated deployment: their own compute, their own database, their own Redis cache, their own backups.
This is not a limitation — it is the model. FDA auditors and ISO 13485 QA teams strongly prefer that customer data never co-mingles with another manufacturer's stack. Each customer's environment is audited independently.
Siloed SaaS is a compliance feature, not a technical compromise.
- ✓ Dedicated compute instance per customer
- ✓ Isolated PostgreSQL database
- ✓ Separate Redis cache
- ✓ Independent automated backups
- ✓ Independent security patching
- ✓ Independent FDA audit scope
- ✓ No cross-customer data access (by design)
- ✓ New environment provisioned in < 30 minutes