SimplerQMS
SimplerQMS A/S is a Copenhagen-based SaaS provider of cloud-based, pre-validated Quality Management System (QMS) software purpose-built for regulated life science companies including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO organizations.
- Company typePrivate
- Founded2017
- HeadquartersCopenhagen, Denmark
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What SimplerQMS does
SimplerQMS A/S is a privately held Danish SaaS company founded in 2017 that develops and sells a cloud-based, pre-validated Quality Management System (QMS) platform exclusively for regulated life science organizations. Its target customers span medical device manufacturers, pharmaceutical and biotechnology companies, clinical and medical laboratories, and contract research, development, and manufacturing organizations (CROs/CMOs/CROs). The company is led by co-founders Jacob Sjørslev Hyrdum (CEO), Allan Murphy Bruun (Business Development Director), Anders Toxboe (CTO), and Marc Murphy Bruun (CFO), all of whom are former leaders at Ambu and bring decades of FDA, ISO, and GxP experience.
The product is a modular platform consisting of fifteen integrated modules — including Document Control, Training Management, Change Management, Design Control, Deviation Management, Nonconformance Management, CAPA Management, Complaint Management, Audit Management, Risk Management, Equipment Management, Supplier Management, Quality KPIs, Electronic Batch Records, and Product Management. It is hosted on AWS infrastructure with SOC 2-compliant Microsoft Azure backing, certified to ISO 13485:2016 and ISO/IEC 27001:2022, and delivered fully validated per ISPE GAMP 5 with pre-packaged IQ/OQ/PQ documentation. Differentiating technology includes native integration with Microsoft 365 and Microsoft Copilot AI for in-application document workflows, plus API-based integrations with ERP, CRM, PLM, WMS, LIMS, MES, and ELN systems. The platform supports compliance with 30+ regulatory frameworks including FDA 21 CFR Parts 11, 210-211, 212, 4, and 820, EU MDR/IVDR/Annex 11, ICH Q9/Q10, ISO 13485, ISO 14971, and others.
Revenue is generated through an all-inclusive annual SaaS subscription with four tiered licenses (Viewer free, Light, Standard, Full) plus implementation, validation, hosting, training, and 24/7 support. GTM combines product-led free demo bookings with inside sales via Denmark and US phone lines and enterprise field sales supported by quality solution experts. The company reports being trusted by 5,000+ life science professionals across a 15,000+ professional community, with strong third-party review ratings (4.9 on G2, 4.6 on Capterra) and named enterprise customers such as Cook Medical, Volpara Health, Basic Pharma, Reapplix, and MedAustron. Implementation cycles of 5–6 weeks and a productivity uplift claim of up to 50% are core commercial messages.
SimplerQMS firmographics
Firmographics- Name
- SimplerQMS
- Legal name
- SimplerQMS A/S
- Website
- https://simplerqms.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- SimplerQMS A/S is a Copenhagen-based SaaS provider of cloud-based, pre-validated Quality Management System (QMS) software purpose-built for regulated life science companies including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO organizations.
- Ownership category
- akta.pro rank
SimplerQMS industry classification
Industry- Product category
- Quality Management Software (Life Sciences)
- NAICS
- Software Publishers (5132), Software Publishers (51321)
- SIC
- Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industry
- Cloud Compliance, Audit & Continuous Controls Monitoring (CCM/GRC) (HDABAHAI)
Keywords
Where SimplerQMS is headquartered
LocationHeadquarters
- HQ city
- Copenhagen
- HQ country
- Denmark
- HQ region
- Europe
Offices1 record
Markets served
SimplerQMS business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Infrastructure, Marketing or Sales, Operations
Revenue model
- Annual SaaS Subscription: Subscription-based annual license covering all QMS modules, implementation, validation, cloud hosting, training, and 24/7 support. All-inclusive pricing model with no hidden fees or add-ons.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Freemium | Annual | Viewer License - Free read-only access for auditors, consultants, external collaborators |
| Subscription | Annual | Light License - Limited functionality for production operators, lab technicians, executives |
| Subscription | Annual | Standard License - Document control plus any two QMS modules |
| Subscription | Annual | Full License - Complete access to all QMS modules and administrative features |
Go-to-market motion3 records
Distribution channels3 records
Marketing channels7 records
SimplerQMS product offering
Product offeringCore offering
SimplerQMS sells a cloud-based, fully validated Quality Management System (QMS) software platform purpose-built for life science companies operating in pharmaceutical, biotechnology, medical device, laboratory, and CRO/CMO sectors. The platform is delivered as an annual SaaS subscription with all-inclusive pricing that bundles the core QMS platform, multiple integrated modules (Document Control, Training, Change Control, CAPA, Audit, Risk, etc.), implementation, validation documentation, cloud hosting, training, and 24/7 support.
Product overview
SimplerQMS is a cloud-based, fully validated Quality Management System (QMS) software built specifically for regulated life science companies. The platform operates as a unified platform-plus-modules architecture, providing a central QMS software with integrated modules including Document Control, Training Management, Change Management, Design Control, Deviation Management, Nonconformance Management, CAPA Management, Complaint Management, Audit Management, Risk Management, Equipment Management, Supplier Management, Quality KPIs, Electronic Batch Records (EBR), and Product Management. The platform integrates natively with Microsoft 365 and Copilot AI, supports ERP, CRM, PLM, WMS, LIMS, MES, and ELN systems via API, and is designed for pharma, biotech, medical devices, laboratories, and CROs/CMOs. SimplerQMS offers subscription-based all-inclusive pricing covering all modules, implementation, validation, training, hosting, and 24/7 support.
Differentiator
Problem solved
Functional benefit
Products and services
- SimplerQMS Cloud QMS Platform Cloud-based, fully validated Quality Management System (QMS) SaaS platform for regulated life science companies, integrating document control, training, change control, CAPA, audits, risk, equipment, supplier management, design control, deviations, nonconformances, complaints, quality KPIs, electronic batch records, and product management in one validated system with native Microsoft 365 and Copilot AI integration and API connectivity to ERP, CRM, PLM, WMS, LIMS, MES, and ELN systems.
Companies that use SimplerQMS
Customer profileNamed customers16 records
Segments7 records
Ideal customer profiles3 records
SimplerQMS technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration9 records
AI capability3 records
Feature7 records
SimplerQMS partnerships and signals
Strategic signalScale indicators7 records
Recent moves6 records
Expansion highlights6 records
SimplerQMS competitors and assessment
Company assessmentBroad incumbents
- ETQ (Hexagon): ETQ, part of Hexagon's Asset Lifecycle Intelligence division, is an established QMS / quality management platform used across manufacturing and life sciences for document control, CAPA, audits, risk, and supplier quality. It represents a broader, more enterprise-oriented alternative to SimplerQMS with deep IT integration capabilities.
- Veeva Systems: Veeva provides industry cloud solutions for life sciences, including Veeva Vault Quality (QMS, document management, training, audit) alongside its broader Vault suite for clinical, regulatory, and commercial. It competes with SimplerQMS primarily in the largest global pharma/biotech accounts where Veeva's breadth and scale are decisive.
- MasterControl: MasterControl is an established incumbent QMS platform serving life sciences and other regulated industries, with document control, change control, CAPA, training, audit, supplier, and quality event modules aligned to FDA, ISO, and GxP. It is a broader, more enterprise-focused alternative to SimplerQMS with a longer operating history and larger customer base.
- Sparta Systems (TrackWise): Sparta Systems' TrackWise is a long-established enterprise QMS platform widely used in life sciences for CAPA, change control, audits, complaints, and document management, now part of Honeywell. It competes with SimplerQMS at the large-enterprise end of the market where TrackWise's install base and validation heritage are decisive.
- Dassault Systèmes BIOVIA: BIOVIA provides scientific and quality management solutions for life sciences and chemicals, including electronic lab notebooks, formulation, and QMS-adjacent capabilities used by large pharma and biotech. It overlaps with SimplerQMS in regulated R&D and quality workflows and represents a broader, science-platform competitor with far greater scale.
Direct peers
- Qualio: Qualio is a cloud-based eQMS for life sciences (pharma, biotech, medical devices, combination products) covering document control, training, change control, CAPA, complaints, and audits with strong regulatory positioning. It is one of the most direct competitors to SimplerQMS, with overlapping customer segments, similar GAMP-style validation messaging, and comparable PLG-driven mid-market GTM.
- Greenlight Guru: Greenlight Guru is a cloud-native eQMS built specifically for medical device and life sciences companies, offering document control, design control, CAPA, risk, and audit modules with FDA 21 CFR Part 11 and ISO 13485 alignment. It directly competes with SimplerQMS in the same buyer segment (medical device QA/RA leaders) with a similar mid-market SaaS motion.
- ComplianceQuest: ComplianceQuest is a native Salesforce EQMS platform covering document control, change, CAPA, audit, supplier, training, and risk management, with strong positioning in life sciences and medical devices. It overlaps significantly with SimplerQMS on functionality and target buyer, and competes through Salesforce ecosystem partnerships.
Emerging players
- AssurX: AssurX provides configurable quality and compliance management software (document control, CAPA, audits, supplier, training) used heavily in medical device, pharma, and other regulated manufacturers. It is a niche, similarly sized competitor to SimplerQMS in mid-market regulated eQMS deals.
- Dot Compliance: Dot Compliance offers AI-enabled eQMS solutions on the Salesforce platform targeting pharma, medical devices, and combination products with document control, training, CAPA, audits, and supplier management. It is a similarly sized, growth-stage competitor to SimplerQMS, differentiated by AI and Salesforce-native delivery.
Market position
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
SimplerQMS social profiles
Digital presenceSimplerQMS compliance and trust
Trust signalCompliance29 records
SimplerQMS financial estimates
Financial estimateRevenue estimate
Valuation estimate
SimplerQMS leadership team
Management profileNumber of profiles
Profiles8 records
SimplerQMS funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SimplerQMS M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SimplerQMS
What does SimplerQMS do?
SimplerQMS sells a cloud-based, fully validated Quality Management System (QMS) software platform purpose-built for life science companies operating in pharmaceutical, biotechnology, medical device, laboratory, and CRO/CMO sectors. The platform is delivered as an annual SaaS subscription with all-inclusive pricing that bundles the core QMS platform, multiple integrated modules (Document Control, Training, Change Control, CAPA, Audit, Risk, etc.), implementation, validation documentation, cloud hosting, training, and 24/7 support.
Is SimplerQMS a public or private company?
SimplerQMS is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was SimplerQMS founded?
SimplerQMS was founded in 2017. It employs 11 to 50 people.
Where is SimplerQMS based?
SimplerQMS is headquartered in Copenhagen, Denmark, in the Europe region.
How does SimplerQMS make money?
One revenue line is on record: annual SaaS Subscription.
Who are SimplerQMS's main competitors?
Broad incumbents on record are ETQ (Hexagon), Veeva Systems, MasterControl, Sparta Systems (TrackWise) and Dassault Systèmes BIOVIA. Direct peers are Qualio, Greenlight Guru and ComplianceQuest. Emerging players are AssurX and Dot Compliance.
Does SimplerQMS have an API?
Yes. SimplerQMS supports integration with ERP, CRM, PLM, WMS, and other applications through an application programming interface (API). The API enables scalable interoperability with clinical, regulatory, IT, and R&D platforms. Validated integration ensures data harmonization, compliance with controlled vocabulary, and alignment with validation lifecycle documentation (IQ/OQ/PQ).
What industry is SimplerQMS in?
SimplerQMS's product category is Quality Management Software (Life Sciences). Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HDABAHAI, Cloud Compliance, Audit & Continuous Controls Monitoring (CCM/GRC). Its NAICS code is 5132 and its SIC code is 7372.