Document Control & e-Sign
Controlled documents and Part 11-designed electronic signatures, built into the platform.
- QMS platform tour — versioned documents, approval workflow, read receipts, periodic review.
- Quality solution — change control with e-signature ceremonies and an append-only record.
- Trust center — how signatures, re-authentication, and the tamper-evident audit trail work.
CAPA & Nonconformance
Corrective and preventive action with the NCRs, complaints, and findings that feed it.
- QMS platform tour — CAPA with effectiveness checks, auto-linked to source records.
- Quality solution — NCR disposition workflow and the connected evidence chain.
- FDA-ready QMS playbook — standing up CAPA/NCR processes from zero.
Audits & Suppliers
Internal, supplier, and external audits — with supplier qualification in the same database.
- QMS platform tour — audit management with finding tracking.
- Operations & ERP — vendor records with risk tiers and qualification status.
- FDA-ready QMS playbook — the audits and supplier-controls stage.
Post-Market Surveillance
Complaints, vigilance, and MDR timelines — captured with the affected unit context.
- Quality solution — complaints and vigilance with the MDR clock.
- Support & tickets — field signals linked to bugs, units, and quality records.
Risk & Design Controls
ISO 14971-aligned risk plus the requirement-to-release traceability auditors ask for.
- QMS platform tour — FMEA-style risk register linked to design controls.
- Traceability matrix — requirement → spec → test → release, generated from real links.
- Engineering & R&D — design reviews, changes, and release evidence.
Training & Competence
Per-person training records that live with the documents and the people they cover.
- Quality solution — document and training control with read receipts.
- HR & People — training records beside the employee directory and roles.
- FDA-ready QMS playbook — the training & competence stage.
MDSAP & Regulatory
MDSAP cycle preparation and the regulatory context around the QMS.
- QMS platform tour — mock external audit prep for MDSAP cycles.
- FDA-ready QMS playbook — from zero to FDA-ready with MDSAP in scope.
- Azora vs Greenlight Guru — how we compare for regulated device teams.
Evidence & Validation
What we claim, what we ship, and the validation package behind it.
- Trust center — security, Part 11 data integrity, validation, reliability, roadmap.
- Architecture brief — the technical foundation, no NDA required.
- Tenant isolation — the multi-tenant model buyers evaluate.