SimplerQMS
The QMS software built by life science experts for regulated life science companies
By SimplerQMS A/S · HQ København, Denmark · 4.5/5 Value-Position score (estimate)
Positioning guardrails
Best for
- Regulated life science teams (pharma, biotech, medical devices, labs, CRO/CDMO) that need a fully validated eQMS with 21 CFR Part 11 and GAMP 5 documentation included.
- Small quality teams (up to 50 employees) wanting preconfigured life-science workflows and templates to reach compliance quickly.
- Growing and global organisations (50–500+ employees) needing multi-site quality operations, CAPA, audits and supplier quality in one system.
- Companies that want implementation, IQ/OQ/PQ validation, data migration and unlimited training bundled into one subscription price.
Ideal size: 15–500+ people · Regulated life science company with an in-house QA/RA function and audit obligations
Not for
- Non-regulated industries with no FDA, ISO 13485 or GxP obligations.
- Organisations that only need lightweight document storage without validated workflows or audit trails.
- Teams wanting self-serve signup and a free forever tier rather than a scoped demo and quote.
- Small buyers under 15 users seeking a low-cost entry point, given the USD 17,500 annual minimum.
Value metrics scorecard
Time-to-Value
About 5–6 weeks to go live
~42 days to first production value
Total Cost of Ownership
$17,500/yr
Starts at $17,500 · Per-user annual subscription with role-based license types (Viewer, Light, Standard, Full); implementation, validation, training, hosting and support included in the price
Implementation Friction
2/5
Engineering + admin effort required
Value-Position score
out of 5 · model estimate
Full cost breakdown
Mandatory implementation fee
None
Seat tiers
Minimum subscription USD 17,500 per year covering up to 15 users; Viewer licenses are free; additional licenses are pro-rated mid-term
Add-on costs
- Extra user licenses beyond those included in the subscription, billed pro-rated until renewal
- Additional storage beyond what ships with each Full and Standard license
Company & support
Who is behind SimplerQMS, and how your team gets help once it is live.
Company
- Founded
- 2017 · 9 yrs in business
- Headquarters
- København, Denmark
How you get support
- PhoneAll plans
- EmailAll plans
- Live chatNot listed
- Support portal / ticketsNot listed
- Community forumNot listed
- Help centre / docsAll plans
- Dedicated account managerEnterprise only
- In person / on-siteNot listed
- Hours
- 24/7
- Response time
- Not stated
Every subscription includes 24/7 emergency phone support plus unlimited live training, validation and audit assistance; support is delivered by phone, email and video call. Dedicated Customer Success experts come with the Full license tier.
“Not listed” means the vendor’s public pages don’t mention that channel, not that it is unavailable. Ask about it during evaluation.
Market position
Where SimplerQMS sits against its closest alternatives. Pick any two of cost, speed, friction and buyer score, and up to 9 companies to compare.
Quadrant view
Typical annual cost × Time-to-value
The lines cross at the median of the solutions shown, so about half sit on each side of each line.
Companies on the chart 6 / 10
- SimplerQMS
- Blumira
- Mimecast
- Afi
- Sharetru
- Hyperproof
Add or change companies
Up to 10 companies including SimplerQMS. Listed closest first.
Stack fit signal
Compatibility with standard B2B ecosystems.
No supported MCP path today, so it cannot be driven from an AI client.
AI & MCP readiness
What SimplerQMS ships in AI, and what it asks of your ecosystem.
AI features shipped
The only AI capability described on the vendor's pages is a native Microsoft 365 integration that lets users work with Microsoft Copilot (AI assistant) in Word, Excel and PowerPoint. No proprietary models, AI governance or AI training statements are published.
Your data & models
- Trains on your data
- Not recorded — ask the vendor
- Runs on
- Not recorded
- AI pricing
- Not recorded
In your ecosystem
- AI connection
- Not supported
- Model key
- Not recorded
- AI usage audit
- Not recorded
Compliance attestations
* IAPP AIGP certifies individuals, not products. It means named staff hold the credential — not that the platform does.
Bottom line
SimplerQMS is a validated, cloud-based eQMS for regulated life science companies: pharma, biotech, medical devices, laboratories and CROs/CDMOs. Modules cover document and change control, training, CAPA, deviations, audits, risk, equipment and suppliers, with 21 CFR Part 11 e-signatures and audit trails. Per-user annual subscriptions start at USD 17,500 for up to 15 users, with implementation, GAMP 5 validation (IQ/OQ/PQ), migration, hosting and training included. Typical go-live is around six weeks.
Frequently asked questions
How much does SimplerQMS cost and what is included?
Pricing is a per-user annual subscription with a minimum of USD 17,500 covering up to 15 users; larger teams receive a tailored quote based on license mix. Integrated QMS modules, implementation, IQ/OQ/PQ validation, data migration, unlimited live training, cloud hosting, life-science templates and 24/7 support are all included, and the vendor states there are no separate onboarding or hidden fees.
How long does implementation take?
The vendor states about six weeks on average for the first implementation phase, guided by a dedicated project manager and training specialists covering configuration, data migration and training. The timeline can be extended if the organisation prefers to move at its own pace, and customers report going live in roughly six weeks.
Is SimplerQMS validated and audit-ready?
Yes, per the vendor. SimplerQMS is delivered fully validated according to ISPE GAMP 5 and compliant with FDA 21 CFR Part 11 and EU GMP Annex 11, with continuously updated IQ/OQ/PQ documentation, Part 11 e-signatures and time-stamped audit trails. SimplerQMS also states that it is certified to ISO 13485:2016 and ISO/IEC 27001:2022 and hosts on AWS with certified infrastructure.
Which systems does SimplerQMS integrate with?
The vendor describes native Microsoft 365 integration for Word, Excel and PowerPoint plus a Microsoft Copilot AI assistant, single sign-on through Microsoft Entra ID or Google Workspace, and API-based integration with ERP, CRM, PLM, WMS, LIMS and other systems. Jira is also named as an integration target.
Is SimplerQMS suitable for companies outside life sciences?
It is purpose-built for regulated life science organisations, so buyers without FDA, ISO 13485 or GxP obligations will likely find it heavier and more expensive than generic document or quality tools. Organisations that need only shared document storage, or clinics needing scheduling, billing and EHR functions, are a weaker fit.