Every regulated business needs a quality foundation before it can scale compliance. QMS Core configures your organizational structure, access controls, quality policy, and audit trail from day one — across all six regulated industries.
QMS Core is the mandatory foundation layer for all Affinity QMS subscriptions. Every other module builds on the infrastructure it establishes.
Organizational Structure Configuration
Define your company hierarchy, sites, departments, and business units. QMS Core adapts its structure to how your organization actually operates — not the other way around. Multi-site and multi-vertical configurations are supported from the start.
Role-Based Access Control (RBAC)
Assign granular permissions by role, department, or individual. Control who can view, edit, approve, and sign quality records. RBAC is enforced across every module — ensuring your quality data is visible to the right people and no one else.
Quality Policy and Objectives Management
Document, version-control, and communicate your quality policy and measurable quality objectives. Link objectives to departments and track progress over time. Required by ISO 13485 Clause 5.3 and 21 CFR Part 820 — managed in one place.
Management Review Scheduling and Records
Schedule recurring management reviews, generate agenda templates pre-populated with quality metrics, and record meeting outputs and action items. Every management review is archived with attendees, decisions, and follow-up assignments — audit-ready from day one.
Process Interaction Map
Visualize and document how your quality processes interact with each other — a requirement of ISO 13485 Clause 4.1 and the FDA QMSR. Define process inputs, outputs, owners, and linkages. Auditors can see your process architecture at a glance.
Dashboard and Compliance Health Metrics
The QMS Core dashboard surfaces your real-time compliance posture — open CAPAs, overdue reviews, training gaps, expiring documents, and audit findings. Role-based dashboards show each user exactly what they are accountable for, and nothing they are not.
21 CFR Part 11 Compliant Audit Trail
Every record creation, edit, approval, and deletion is logged in a tamper-evident audit trail with timestamp, user identity, and change reason. Electronic signatures meet 21 CFR Part 11 requirements. The audit trail is read-only, exportable, and always available for FDA inspection.
QMS Core satisfies the foundational requirements of every major regulatory framework Affinity QMS supports — across all six verticals.
| Regulation / Standard | Clause / Section | QMS Core Coverage |
|---|---|---|
| 21 CFR Part 820 (FDA QMSR) | Subpart A — General Requirements | Quality system establishment, organizational authority, management responsibility |
| ISO 13485:2016 | Clauses 4.1, 5.1, 5.3, 5.4, 5.6 | QMS scope, management commitment, quality policy, objectives, management review |
| FDA QMSR (2024) | 820.20 Management Responsibility | Quality policy, organizational structure, management review records |
| 21 CFR Part 111 | Subpart B — Personnel | Role assignments, access controls, qualification records |
| 21 CFR Part 211 | Subpart B — Organization and Personnel | Organizational hierarchy, responsibility segregation, quality unit independence |
| ISO/IEC 17025:2017 | Clause 8.2 — Management System | Quality policy documentation, objectives, management system review |
| 21 CFR Part 11 | Electronic Records and Signatures | Audit trail, electronic signatures, record integrity |
| SQF Code / BRCGS | Senior Management Commitment | Quality policy, management review scheduling and records |
Starting at
$299/mo
QMS Core is included in the QMS Core tier ($299/mo) and every tier above it. It is the mandatory foundation of every Affinity QMS subscription — you cannot activate any other module without it.
QMS Core is the foundation. Add modules as your compliance requirements grow.
QMS Core configures to your organization in hours — not months. Book a demo and see it adapt to your process in real time.