SimplerQMS
Copenhagen eQMS delivered pre-validated for pharma, biotech and medical device companies, with a starter price shown on its site
Quick Overview
| Company | SimplerQMS A/S |
|---|---|
| Category | Quality Management Software (QMS) |
| Headquarters | Copenhagen, Denmark |
| Founded | Not stated |
| EU Presence | Yes - Denmark (EU) |
| Data Location | Amazon Web Services and Microsoft Azure (as stated by the vendor) |
| Open Source | No |
| GDPR Compliant | Yes |
| Self-Hosting | No |
| Main Features | Document control, change control, CAPA, training, audits, supplier management, equipment records, design control and risk management, validation pack, viewer licences for auditors |
| Pricing | Starter from USD 17,500 per year for up to 15 users; Team and Enterprise on quote |
| Best For | Life science teams that want validation and onboarding bundled into one yearly fee |
| Replaces | MasterControl, Veeva Vault QMS |
Detailed Review
SimplerQMS A/S is registered in Copenhagen under CVR number DK39039923, and its privacy policy names the Danish Data Protection Agency as the supervisory authority. The company was started by former managers of the Danish medical device maker Ambu.
The vendor itself holds an ISO 13485:2016 certificate and states ISO/IEC 27001:2022 controls, which matters to procurement teams that audit their suppliers.
Validation inside the subscription
The site says the software is delivered validated according to ISPE GAMP 5, and the pricing page lists implementation, onboarding, validation, user training and cloud hosting as part of the subscription rather than as extras.
That bundling is the main difference from buying a platform and a validation project separately.
Licence types by role
A free Viewer licence gives invited auditors and collaborators read-only access under an active subscription. Lighter and full licence types are combined to match how often each person edits records.
A published entry price
The Starter plan is shown as starting from USD 17,500 annually for up to 15 users, and larger teams are quoted. Few eQMS vendors show any figure, so this gives a rough budget line before a demo.
Limitations to Consider
The listed price is in US dollars and the starter tier is sized for teams that already have a funded quality function, which can be heavy for a seed-stage startup. Hosting runs on Amazon Web Services and Microsoft Azure, both US-parented providers, which some buyers will weigh against the Danish contracting entity. The product is aimed at life sciences, so general ISO 9001 manufacturers will find Babtec or CAQ AG closer to shop-floor needs.
Who Should Use SimplerQMS
Pharma, biotech, medical device and laboratory companies that want a validated eQMS with onboarding bundled and a certified Danish vendor.
Pros and Cons
Pros
- Vendor holds an ISO 13485:2016 certificate
- Validation, training and hosting bundled in the fee
- Starter price visible on the website
- Free read-only licences for auditors
- Danish A/S with CVR registration
Cons
- Price shown in USD only
- Hosted on US-parented cloud providers
- Aimed at life sciences, not general manufacturing
- Starter tier can be heavy for tiny teams
Alternatives to SimplerQMS
Other European quality management software (qms) worth comparing before you decide:
Qualio
Ireland · Cloud eQMS for medtech and biotech with AI gap analysis
Scilife
Belgium · Brussels eQMS for pharma and medical devices with module tiers
OpenRegulatory (Formwork)
Germany · Low-cost eQMS and technical documentation for medical device startups
Cognidox
United Kingdom · Cambridge eQMS built on document control for device developers
See all European quality management software (qms) or compare them directly against MasterControl on our alternatives page.
Frequently Asked Questions
Yes. Its privacy policy names SimplerQMS A/S at Nannasgade 28 in Copenhagen with CVR number DK39039923.
The pricing page states a start from USD 17,500 annually for up to 15 users, with implementation, validation, training and cloud hosting included.
Yes. The Viewer licence is free for invited auditors and collaborators with read-only access, as long as the subscription is active.