The QMS That Adapts to You.
Every other quality management system asks you to change how you work. Affinity QMS changes to fit you — across medical devices, dietary supplements, OTC drugs, 503B outsourcing, ISO 17025 labs, and food & beverage.
21 CFR Part 820 · ISO 13485 · FSMA · ISO 17025 · 21 CFR Part 111 · 21 CFR Part 211
Every QMS Was Built for Someone Else.
Every QMS on the market was built for someone else's process. You've spent months configuring it, training your team around it, and calling consultants to explain why it doesn't match how you actually work. And you're still not compliant.
The enterprise players — Greenlight Guru, MasterControl, Veeva — are built for companies three times your size with teams twice your budget. The cheaper tools are too rigid to scale. None of them adapt to you.
Rigid Systems That Force Process Rebuilds
Your existing SOPs, workflows, and quality records were built for your business — not a software vendor's template. Legacy QMS platforms make you rebuild from scratch.
Separate Validation Packages Sold at Extra Cost
IQ/OQ/PQ validation protocols shouldn't cost $15,000–$50,000 in consultant fees on top of your software subscription. Every. Single. Activation.
Industry-Specific Platforms That Cannot Grow With You
Built for one vertical, locked into one framework. When your business diversifies or your regulatory obligations expand, you're back to square one.
One Adaptive Platform. Any Regulated Industry.
Built for companies from pre-submission to Series B — and every regulatory framework in between.
Medical Devices
DHF/DMR, CAPA, complaint management, and the Validation Protocol Engine — everything a medtech startup needs from pre-submission to MDSAP.
Dietary Supplements
21 CFR Part 111 cGMP compliance for supplement brands and contract manufacturers — from supplier qualification to label claim substantiation.
OTC Drugs
cGMP compliance for OTC drug manufacturers — validation requirements, batch record documentation, and FDA pre-approval inspection readiness.
503B Outsourcing
Quality systems for 503B outsourcing facilities — sterile compounding documentation, FDA registration support, and USP 797/800 compliance.
ISO 17025 Labs
ISO/IEC 17025:2017 quality management for testing and calibration laboratories — accreditation audit preparation, method validation, and inter-lab proficiency tracking.
Food & Beverage
FSMA-compliant quality management for food manufacturers — HARPC plan documentation, SQF audit readiness, and supplier approval programs.
Three Steps to Compliance.
No 18-month implementations. No process rebuilds. No consultants just to get started.
Configure
Tell us how you work. Affinity QMS configures to your existing processes — your SOPs, your workflows, your organizational structure. Not the other way around.
Activate
Add only the modules you need. QMS Core, Document Control, CAPA, DHF/DMR, Validation Engine — a-la-carte. Pay for what you use, expand when you're ready.
Comply
The platform generates your validation protocols, tracks your regulatory obligations, and keeps you audit-ready — from your first FDA submission to your hundredth.
Everything Your QMS Needs. Nothing It Doesn't.
Eleven modules, a-la-carte. Activate what you need today and expand as your compliance obligations grow.
QMS Core
Foundation layer for your quality management system — organizational structure, document framework, and baseline compliance infrastructure.
Document Control
SOPs, work instructions, revision management, e-signatures, and controlled document workflows — automated and audit-ready.
CAPA Management
Corrective and preventive actions, root cause analysis, effectiveness checks, and CAPA closure tracking across all verticals.
Complaint Management
Complaint intake, MDR and adverse event tracking, trending, and regulatory reporting — built to FDA standards.
Deviations & Nonconformances
NCR workflow, disposition tracking, containment actions, and root cause linkage — close out findings before they become findings.
Audit Management
Internal and external audit scheduling, findings management, CAPA linkage, and audit program oversight in one place.
DHF / DMR Management
Design History File and Device Master Record management — structured, linked, and 21 CFR Part 820 / ISO 13485 compliant.
Risk Management
ISO 14971 risk register, FMEA workflows, risk-benefit analysis, and residual risk tracking — built for medical devices and beyond.
Supplier Management
Approved vendor list, supplier qualification, incoming inspection records, and supplier corrective action requests — all linked.
Training Management
Training records, competency tracking, SOP acknowledgment workflows, and training effectiveness documentation — audit-ready by default.
Validation Protocol Engine
Auto-generates IQ/OQ/PQ validation protocols for every module you activate. No canned package. No consultant fees. Hand the VP to your auditor on day one.
The Only QMS That Validates Itself.
Affinity QMS auto-generates IQ/OQ/PQ validation protocols for every module you activate. No canned package. No manual updates. No $15,000–$50,000 in consultant fees. Your auditor asks for VPs — you hand them over.
See the Validation Engine →Start With What You Need.
A-la-carte module pricing means you never pay for features you're not using.
Validation Protocol Engine — $349/mo add-on
Auto-generates your IQ/OQ/PQ protocols — no canned package, no consultant fees. Included in Compliance Suite and Full Platform. See the VP Engine →
Built for Every Major Framework.
Affinity QMS maps directly to the regulatory frameworks that govern your industry.
"We've been through three QMS implementations in five years. Affinity is the first platform that actually configured to our process instead of the other way around. We were audit-ready in 90 days."— Design Partner, Medtech Startup (Beta Program)
Stop Fitting Your Process to Your QMS.
Book a 30-minute demo and see how Affinity QMS adapts to your industry, your process, and your stage of growth.