SimplerQMS A/S

SimplerQMS A/S is a Danish company founded in 2017 by former Ambu executives Jacob Sjørslev Hyrdum (CEO) and Allan Murphy Bruun (Business Development Director). The founding team brings 30+ years of combined experience in life-science quality management. Hyrdum previously served as CIO at Ambu overseeing international IT operations including ERP, PLM, CRM, and compliance systems. Bruun served as Business Systems Consultant at Ambu responsible for implementing validated business applications.

SimplerQMS develops cloud-based eQMS software specifically for life science organizations including pharmaceutical, biotech, medical device, laboratory, and CRO/CMO companies. The platform serves over 4,300 quality professionals globally. The company is ISO 13485:2016 certified and provides a fully validated GAMP 5 Category 4 system with IQ/OQ/PQ documentation.

SimplerQMS is headquartered in Copenhagen, Denmark with additional offices in Manila, Philippines and San Diego, California. The company employs 12 people as of November 2024, representing 33% growth from November 2023. Recently relocated headquarters to Schillerhuset office hotel in Nørrebro, Copenhagen.

The company's mission is to help life-science companies work efficiently with their documentation through an all-inclusive QMS platform with integrated modules, Microsoft Office 365 integration, unlimited training, and 24/7 support.

Life sciences specialist serving pharmaceutical, biotech, medical device, laboratory, and CRO/CMO organizations exclusively. Over 4,300 quality professionals use SimplerQMS globally. Named pharmaceutical customers include Basic Pharma (CDMO with 200+ employees) and pharmaceutical manufacturing organizations. Customer base also includes Minerva Imaging, Reapplix, Cook Medical, LiNA Medical, Cortex, Cortrium, Volpara Health, Circuit Clinical, RPO Clinical, MedAustron, Biograil, and Capitainer.

Pharma-specific capabilities include GMP/GxP compliance support, FDA 21 CFR Parts 210/211/820 compliance, ICH Q10 support, electronic batch records (EBR), and document management automation for pharmaceutical workflows. The system is fully validated according to GAMP 5 (Category 4), with IQ/OQ/PQ validation documentation provided. Testimonials from pharmaceutical QA managers describe the system's terminology as carrying its medical-device origins rather than pharma-specific GMP vocabulary. Customers report successful FDA inspections and auditor commendations for system quality.

Bootstrapped, private company with no disclosed external funding, VC investment, or revenue figures. Crunchbase lists the company with no funding rounds recorded. Added 160+ customers in 2024, a 14% increase. Employee count grew 33% from November 2023 to November 2024, from 9 to 12. Serves over 4,300 quality professionals globally.

SimplerQMS offers a single integrated eQMS platform with 14 modules: document control, training management, change management, design control, nonconformance & deviation management, CAPA, complaint management, audit management, risk management, equipment management, supplier management, electronic batch records (EBR), and product management. All-in-one suite approach with no separate product editions.

Additional features include Microsoft Office 365 integration for document editing (Word, Excel, PowerPoint), automated audit trail documentation, continuously updated validation packages (IQ/OQ/PQ), and all-inclusive pricing bundling software, implementation, validation docs, unlimited training, cloud hosting, and 24/7 support. Cloud-based SaaS platform accessible via web browser with no software installation required. An API is available for integrations with other business applications. The platform is hosted on cloud infrastructure with enterprise-grade security, including data encryption at rest and in transit.

The flagship pharmaceutical-specific feature is the electronic batch records (EBR) module, for paperless batch execution with real-time data capture, electronic signatures, and GMP compliance. Implementation timeline: 5-6 weeks from kick-off to go-live.

Microsoft Office 365 is a disclosed technology partnership, integrating Word, Excel, and PowerPoint into SimplerQMS document-editing workflows. A cloud infrastructure hosting partnership exists; the provider is undisclosed. No implementation partner network is disclosed. The company provides implementation services directly. No affiliations with ISPE, PQG, or FDA partnerships are disclosed. The only integration path disclosed is API availability for custom integrations with other business applications.

24/7 customer support included in all-inclusive subscription pricing with no additional fees. Unlimited training provided to all customers as part of subscription. Professional services include full implementation (5-6 weeks), IQ/OQ/PQ validation documentation continuously updated and provided to all customers, data migration support, and pre-built QMS templates.

Four-phase implementation approach: Analysis (current QMS review, GAP analysis, design workshop), Configuration (system adjustment for organizational needs), Training (instructor-led hands-on sessions for super-users and regular users), Migration (document transfer, review, approval). Super-users dedicate 1-2 days/week during implementation; regular users need 0.5-1 day for training.

Customer success evidenced by case studies showing 50% reduction in change management time (Cortex), 50% faster employee onboarding (Minerva Imaging), major productivity boosts (Cortrium), and auditor commendations (Reapplix, Basic Pharma). No user community events or certification programs disclosed.

SimplerQMS is ISO 13485:2016 certified. SimplerQMS A/S is certified to ISO/IEC 27001:2022 at its own ISMS level. No SOC 2 Type II report is disclosed at the application layer. AWS hosting carries its own separate attestations. The system is fully validated according to GAMP 5 (Category 4), in compliance with FDA 21 CFR Part 11 and EU GMP Annex 11. It supports compliance with ISO 9001, GxP, FDA 21 CFR Parts 210/211/820, ICH Q10, and EU MDR/IVDR.

Leadership team of Jacob Sjørslev Hyrdum (Co-founder & CEO) and Allan Murphy Bruun (Co-founder & Business Development Director) brings 30+ years of combined experience from Ambu medical device manufacturer. No Gartner or Forrester analyst recognition. No disclosed awards or industry accolades.

Listed on G2 and Capterra review platforms with active reviews. Customer testimonials highlight exceptional customer service, ease of use, fast implementation, and successful FDA inspections. Customers report auditor commendations during inspections (Basic Pharma, Reapplix).

The website includes a resource centre with a blog, case studies, an implementation guide, and QMS implementation whitepapers. A free demo is offered. Content marketing is active, with regular blog posts on quality management topics. Customer case studies are prominently featured with quantitative outcomes. LinkedIn carries company updates. The news section is limited, with infrequent press releases.

The website publishes pricing transparently, emphasising the all-inclusive model, and includes technical documentation. Implementation speed and customer success stories are the primary marketing emphasis. The vendor markets itself as fast-to-implement and all-inclusive. Visibility is primarily in the European market, based on the Danish headquarters and customer base. Presence in the US market is growing, with the San Diego office and US customers.