SimplerQMS review
Only full QMS here with a published starting price.
Top 11 rank
#3 of 11
Score
7.5/9.4
Pricing
$$$$ (Starter from USD 17,500 per year for up to 15 users; 15+ users is quote only)
HQ
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Verdict
SimplerQMS ranks third because it is the only candidate on this list to publish a starting price for a full QMS, and it includes validation, data migration, implementation and live training in that price.
What customers praise
Starter is stated as USD 17,500 annually for up to 15 users. Every plan includes ISO 13485 and 21 CFR Part 820 templates, IQ/OQ/PQ validation, data migration, unlimited live training and cloud hosting. Viewer licenses for auditors and collaborators are free and unlimited, and Full licenses cover CAPA, audit, supplier, risk and design control.
What customers criticise
The USD 17,500 minimum is a lot for a small shop that needs fewer than 15 seats. Light, Standard and Full license prices are not shown, and Team and Enterprise need a quote. The page gives two storage figures (150,000 documents and 200 GB) and does not reconcile them. It describes no inspection, SPC or first article tools, and the templates are aimed at medical device rules rather than general manufacturing.
Best for
Small regulated manufacturers (medical device, life sciences supply chain) who want a validated, cloud QMS with a price on the page and free read-only access for auditors.
At a glance
- Integrations: CRM, ERP, Jira, Microsoft 365, SSO via Microsoft Entra ID or Google Workspace
- Compliance: 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 13485, 21 CFR Part 820
Red flags
Public risk signals as of October 2026: none. No risk-signal search was run for this entry; none observed on the vendor pages read on 2026-10-19. See the full red-flag report.
Alternatives
See alternatives to SimplerQMS, or compare against the next-ranked entry: SimplerQMS vs MasterControl.
Source: Top 11 ETQ Reliance vs 1factory vs SimplerQMS: 11 Best Quality Management Software for Small Manufacturers 2026, verified October 19, 2026 — no paid placement.