Transparent, A-la-Carte Pricing
Transparent Pricing. No Sales Call. No Lock-In.
QMS Core from $499/month. Add only the modules you need. Cancel anytime.
Choose Your Plan
Five Tiers. One Adaptive Engine.
Every plan includes unlimited users, white-glove onboarding configuration, and access to our regulatory support team. Cancel or change plans anytime.
QMS Core
$499/mo
Best for: Pre-submission startups and early-stage companies building their first quality system.
Includes- Document Control module
- Training Records & Management
- Supplier Register
- QMS Core foundation layer
- Unlimited users
- Onboarding configuration session
- Regulatory support access
Builder
$999/mo
Best for: Growing QMS teams preparing for their first certification audit or FDA inspection.
Everything in Core, plus- CAPA Management
- Complaint Management
- Deviations & Nonconformances
- Audit Management
- Priority onboarding
- Quarterly compliance check-in
Compliance Suite
$1,799/mo
Best for: Medical device companies, complex regulated manufacturers, and organizations requiring IQ/OQ/PQ validation documentation.
Everything in Builder, plus- DHF / DMR Management
- Risk Management (ISO 14971)
- Validation Protocol Engine
- Auto-generated IQ/OQ/PQ protocols
- Dedicated Customer Success Manager
- SLA: 4-hour response for critical issues
- Monthly regulatory obligation review
Full Platform
$3,499/mo
Best for: Enterprise-adjacent companies, multi-vertical organizations, and MDSAP candidates.
Everything in Compliance Suite, plus- All 11 modules activated
- Special Systems: IEC 62304, AI/ML, Cybersecurity
- Multi-vertical configuration
- MDSAP program support
- White-glove onboarding
- Executive compliance reporting dashboard
Enterprise
Custom
Best for: Multi-site manufacturers, contract organizations serving multiple regulated clients, and enterprise organizations with custom compliance requirements.
Includes- Custom module configuration
- Multi-site deployment
- White-glove onboarding program
- Dedicated Customer Success Manager
- Custom SLA and support agreement
- Integration with ERP, LIMS, or PLM systems
A-la-Carte Add-Ons
Add Individual Modules Starting at $99/mo.
Not ready for a full plan upgrade? Add individual modules to any existing plan at the prices below.
CAPA Management
$149/mo
Complaint Management
$149/mo
Audit Management
$129/mo
Deviations & NCRs
$99/mo
Risk Management
$199/mo
DHF / DMR Management
$249/mo
Validation Protocol Engine
$349/mo
Supplier Management
$99/mo
Training Management
$99/mo
SQF Certification Pack
$149/mo
ISO 17025 Lab Pack
$179/mo
NSF / BRC Cert Pack
$149/mo
Not Sure Which Modules You Need?
Book a 30-minute demo and we'll map your specific regulatory obligations to the exact module set you need — with no upsell and no obligation. We'd rather give you the right answer than the most expensive one. Book your demo →
Flagship Add-On
Validation Protocol Engine
Auto-generates your IQ/OQ/PQ validation protocols — no canned templates, no $15,000–$50,000 consultant engagements.
$349/mo standalone
- ✓ $299/mo when added to QMS Core or Builder
- ✓ Included free in Compliance Suite and Full Platform
- ✓ Included free in all Enterprise tiers
- ✓ Replaces $15,000–$50,000 per validation engagement
- ✓ FDA 21 CFR Part 11 & ISO 13485 compliant outputs
How We Compare
See How Affinity QMS Stacks Up.
Transparent pricing. No sales calls required to see a number.
| Vendor | Entry Price | Pricing Visible? | Sales Call Required? | Validation Protocols |
|---|---|---|---|---|
| Greenlight Guru | ~$25,000+/yr | ✗ Hidden | ✗ Yes | ✗ No |
| Qualio | ~$15,000+/yr | ✗ Hidden | ✗ Yes | ✗ No |
| SimplerQMS | ~$12,000+/yr | ✗ Hidden | ✗ Yes | ✗ No |
| Affinity QMS | $499/mo | ✓ Yes | ✓ No | ✓ +$349/mo |
Competitor pricing estimated from public sources and G2/Capterra reviews. Contact vendors for exact quotes.
Pricing FAQ
Common Pricing Questions.
Yes. Every Affinity QMS plan is designed to grow with you. You can add individual modules a-la-carte at any time, or upgrade to the next plan tier. Module activations take effect immediately, and your validation protocols are generated automatically upon activation.
No long-term contracts on any plan. QMS Core, Builder, Compliance Suite, and Full Platform are all month-to-month subscriptions. You can cancel, downgrade, or upgrade anytime. Enterprise agreements include a minimum term that varies by configuration — your sales contact will walk you through the options.
Pricing is per organization, not per user. Every plan includes unlimited users at no additional charge. You pay for the modules you've activated, not for the headcount of your team. This is a deliberate design decision — compliance tools that charge per user incentivize organizations to limit access, which creates compliance risk.
Any individual with access to your Affinity QMS instance counts as a user. This includes internal team members, contractors, consultants, and auditors who need read access during an inspection. All users are unlimited on all plans — there is no per-seat fee.
Yes. All plans include onboarding configuration sessions where we configure the platform to your existing processes and train your team on the modules you've activated. Compliance Suite and above include a dedicated Customer Success Manager who provides ongoing support, quarterly reviews, and regulatory obligation check-ins.
Yes — this is one of the core reasons Affinity QMS exists. If you operate across multiple regulated verticals (e.g., medical devices and dietary supplements, or food manufacturing with ISO 17025 lab operations), a single Affinity QMS instance can be configured to handle all of them. Contact us for multi-vertical configuration pricing.
We offer a 30-minute live demo tailored to your specific industry and regulatory framework — not a generic product tour. During the demo, you'll see the exact modules and configurations relevant to your compliance obligations. If you'd like a hands-on pilot after the demo, we can arrange a structured 30-day pilot for qualified prospects.
Plan upgrades take effect immediately. Your existing data, configuration, and validation documentation carry over — you never start from scratch when upgrading. Prorated credits are applied when you upgrade mid-billing-cycle. There are no migration fees, re-onboarding fees, or new validation packages required when upgrading between plans.
Enterprise pricing is scoped based on your specific requirements: number of sites, regulatory frameworks, custom integrations (ERP, LIMS, PLM), and support SLA requirements. Contact our sales team at contact page or book a demo to start the conversation. Enterprise agreements typically include volume discounts, custom SLAs, and dedicated Customer Success resources.
Yes. Affinity QMS is hosted on SOC 2 Type II certified infrastructure with end-to-end encryption, role-based access controls, and full audit trail logging. Your data is never shared with third parties, and you retain ownership of all your quality records. We support data export in standard formats at any time — including at contract termination.
Because hidden pricing is a sales tactic, not a business model. Early-stage medtech companies don't have time to sit through three discovery calls just to find out whether a QMS fits their budget. We publish our prices so you can make an informed decision before you ever talk to us. If that transparency means we lose a deal to a competitor who obscures their pricing until after the demo — that's fine with us.
$299/month was our v1.0 launch price for QMS Core. As of July 2026 we moved to v2.0 pricing — QMS Core is now $499/month, reflecting the expanded module set, deeper FDA 21 CFR Part 11 compliance tooling, and the infrastructure investment required to support audit-ready deployments. If you signed up before July 2026, your legacy rate is locked for the life of your subscription.
It depends on your plan. The VP Engine is included at no extra cost in Compliance Suite, Full Platform, and all Enterprise tiers. If you're on QMS Core or Builder, you can add it for $299/month (a $50/month discount vs. the standalone rate of $349/month). If you're not sure whether you need it, read the full VP Engine overview — it replaces $15,000–$50,000 per validation engagement.
Not Sure Which Plan Is Right for You?
Book a 30-minute demo with the Affinity QMS team. We'll map your regulatory obligations to the exact plan and module set you need — with no obligation.