One Engine. Every Regulated Industry. Configure It Your Way.
Eleven modules. Six regulated verticals. Activate only what you need. Expand as your compliance obligations grow. The only QMS that auto-generates its own validation protocols.
11 Modules. One Adaptive Engine.
Each module is designed to work independently or together. Activate the modules that match your current regulatory obligations and add more as you grow.
QMS Core
The foundation layer of your quality management system — organizational structure, document framework, policy management, and baseline compliance infrastructure. Required base for all other modules.
Document Control
SOPs, work instructions, revision management, e-signatures, document approval workflows, and controlled distribution. Every change is tracked, every approval is recorded.
CAPA Management
Corrective and preventive actions, root cause analysis, effectiveness checks, CAPA closure tracking, and FDA 21 CFR Part 820.100 and ISO 13485 Clause 8.5.2 compliance.
Complaint Management
Complaint intake, MDR and adverse event tracking, complaint trending analysis, and regulatory reporting — structured to meet FDA Part 803 and ISO 13485 Clause 8.2.2 requirements.
Deviations & Nonconformances
NCR workflow, disposition tracking, containment actions, root cause linkage, and material review board documentation across all regulated verticals.
Audit Management
Internal and external audit scheduling, audit plans, findings management, CAPA linkage, and audit program oversight — structured for FDA, ISO, and SQF audit cycles.
DHF / DMR Management
Design History File and Device Master Record management — structured, linked records with revision control, 21 CFR Part 820.30 and ISO 13485 Clause 7.3 compliance.
Risk Management
ISO 14971 risk register, FMEA workflows, hazard analysis, risk-benefit analysis, and residual risk tracking — built for medical devices and applicable across all regulated verticals.
Supplier Management
Approved vendor list, supplier qualification records, incoming inspection workflows, and supplier corrective action requests — linked to CAPA and NCR modules.
Training Management
Training records, competency assessments, SOP acknowledgment workflows, training effectiveness documentation, and gap reporting — audit-ready by default.
Validation Protocol Engine
Auto-generates IQ/OQ/PQ validation protocols for every module you activate. Execution tracking, electronic approval workflows, and auditor-ready VP packages — all built in. No consultant fees.
The Only QMS That Validates Itself.
Every other QMS platform sells you a validation package separately — a canned set of documents that cost $15,000–$50,000 in consultant fees and require manual updates every time you change a module configuration.
Affinity QMS auto-generates IQ/OQ/PQ validation protocols for every module you activate. The protocols are generated from your specific configuration — not a generic template. When your configuration changes, the protocols update automatically.
Explore the Validation Engine →Installation Qualification (IQ)
Auto-generated IQ documentation confirming your system is installed correctly against your environment specifications.
Operational Qualification (OQ)
OQ protocols confirming all functions operate within expected parameters under normal operating conditions.
Performance Qualification (PQ)
PQ documentation confirming the system performs consistently in your actual production environment.
Execution Tracking & Approval
Track protocol execution status, record deviations, capture e-signatures, and generate approval packages in a single workflow.
How Affinity Configures to You.
No 18-month implementations. No process rebuilds. No consultants just to get started.
Configure
At onboarding, we map your existing processes, SOPs, and organizational structure into Affinity QMS. Your workflows become the template — not ours.
Activate
Select the modules your current compliance obligations require. Add them a-la-carte at $99–$349/month per module, or choose a bundled plan. Scale up when your obligations grow.
Comply
Validation protocols are generated automatically. Regulatory obligations are tracked. Audit trails are maintained. Your auditor asks for documentation — you hand it over the same day.
Which Modules Satisfy Which Regulations.
Every Affinity QMS module is mapped directly to the specific regulatory clauses it satisfies. Know exactly which modules you need for your compliance obligations.
| Module | 21 CFR 820 | ISO 13485 | 21 CFR 111 | 21 CFR 211 | 21 CFR 117 | ISO 17025 |
|---|---|---|---|---|---|---|
| QMS Core | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Document Control | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| CAPA Management | ✓ | ✓ | ✓ | ✓ | ✓ | Partial |
| Complaint Management | ✓ | ✓ | ✓ | ✓ | Partial | Partial |
| Deviations & NCRs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Audit Management | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| DHF / DMR Management | ✓ | ✓ | — | — | — | — |
| Risk Management | ✓ | ✓ | Partial | Partial | ✓ | Partial |
| Supplier Management | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Training Management | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Validation Protocol Engine | ✓ | ✓ | Partial | ✓ | Partial | ✓ |
Not sure which modules you need? Book a demo and we'll map your regulatory obligations to the right module set.
Ready to Configure Your QMS?
Book a 30-minute demo and see exactly how Affinity QMS adapts to your regulatory obligations, your industry, and your stage of growth.