About SimplerQMS
SimplerQMS is a provider of cloud-based electronic quality management system (eQMS) software built exclusively for regulated life science companies. SimplerQMS pairs in combining purpose-built eQMS software with implementation, validation, training, and ongoing support, with a primarily serving small to mid-sized organizations.
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Company Background
SimplerQMS is a privately held company registered as SimplerQMS A/S. SimplerQMS serves 200 life science customers worldwide.
Company at a glance
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Privately held
SimplerQMS A/S
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200
Life science customers worldwide
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26 countries
Across the Americas, EMEA, and APAC
When Was SimplerQMS Founded?
SimplerQMS was founded in October 2017 in Copenhagen, Denmark.
Who Founded SimplerQMS?
SimplerQMS was founded by Jacob Sjørslev Hyrdum and Allan Murphy Bruun.
Why Was SimplerQMS Created for Life Sciences?
SimplerQMS was created specifically for life sciences after its founders experienced the documentation inefficiencies, software validation requirements, and audit preparation challenges of regulated life science organizations firsthand.
Who Are the People Behind SimplerQMS?
The SimplerQMS leadership team comprises Jacob Sjørslev Hyrdum, Allan Murphy Bruun, Marc Murphy Bruun, and Anders Toxboe. The team brings experience across life sciences, regulated business systems, finance, and technology, supported by a globally distributed workforce.
Jacob Sjørslev Hyrdum
Before co-founding SimplerQMS, Jacob served as Chief Information Officer at Ambu, where he was responsible for global IT systems, compliance, and validation.
Allan Murphy Bruun
Before co-founding SimplerQMS, Allan held roles at Ambu and Aidcube spanning business systems, sales, marketing, and validated system implementation.
Marc Murphy Bruun
Marc oversees finance, HR, and IT at SimplerQMS. His life science experience includes previous roles at Novo Nordisk.
Anders Toxboe
Anders leads product development, platform design, and the technology roadmap for SimplerQMS.
SimplerQMS Products and Services
SimplerQMS combines purpose-built eQMS software with implementation and ongoing customer success services for life science companies. Software, onboarding, validation support, training, hosting, updates, and support are included in the subscription.
Included in Every Subscription
Every subscription combines the SimplerQMS software with the services needed to implement, validate, adopt, and maintain it.
QMS Software
Manage connected quality processes through integrated modules built for regulated life science organizations.
Implementation
Launch core modules in approximately 6–8 weeks with support for configuration, data import, training, validation, and go-live from a dedicated implementation team.
Customer Success Program
Continue working with life science experts after go-live through ongoing training, validation, audit assistance, technical support, templates, and system expansion.
QMS Modules and Quality Processes
SimplerQMS connects core quality processes in one integrated eQMS built for regulated life science organizations.
Why Do Life Science Companies Choose SimplerQMS?
Life science companies choose SimplerQMS for its life science industry specialization, fully validated QMS software, integrated quality processes, and hands-on support from implementation through ongoing use.
Life Science Specialization
Built specifically for regulated life science companies, SimplerQMS aligns with industry quality and compliance requirements.
Expert Knowledge
The SimplerQMS team brings practical experience in life science quality systems, compliance, validation, and regulated operations.
Fully Validated Software
SimplerQMS is delivered as a fully validated eQMS solution with supporting validation evidence with ongoing revalidation in every software release/version update.
Integrated Quality Processes
Documents, training, CAPAs, audits, change control, and related quality activities work together in one connected platform.
Implementation and Customer Success
Customers receive implementation, training, validation support, and ongoing guidance from a dedicated team.
Ongoing Support
SimplerQMS provides continued support after go-live, helping customers maintain, expand, and improve their quality system over time.
SimplerQMS Compliance
SimplerQMS supports regulatory compliance in life sciences through its validated eQMS controls designed for regulated life science quality processes.
What Certification Does SimplerQMS Hold?
SimplerQMS A/S holds ISO 13485:2016 certification for its quality management system.
ISO 13485:2016
Quality Management System
SimplerQMS A/S is certified to ISO 13485:2016 for its quality management system.
How Does SimplerQMS Help With Regulatory Compliance?
SimplerQMS supports regulatory compliance in life sciences through a fully validated eQMS designed to support applicable FDA, ISO, EU, and GxP-related requirements.
SimplerQMS A/S is certified to ISO 13485:2016, and the SimplerQMS software is designed to support and align with the requirements of the ISO 13485 quality management system.
SimplerQMS A/S maintains information security controls aligned with ISO/IEC 27001:2022 across its organization and QMS software platform.
SimplerQMS complies with FDA 21 CFR Part 11.
SimplerQMS supports compliance with FDA 21 CFR Part 820.
SimplerQMS supports GMP requirements under FDA 21 CFR Part 211.
SimplerQMS supports compliance with FDA 21 CFR Part 212.
SimplerQMS support compliance with FDA 21 CFR Part 4.
SimplerQMS supports FDA Data Integrity Guidance (FDA-2018-D-3984) principles.
SimplerQMS supports adherence to CLIA.
SimplerQMS supports compliance with EudraLex Volume 4 GMP (Part 1 – Medicinal Products).
SimplerQMS supports compliance with EudraLex GMP Annex 11: Computerized Systems, Annex 16 QP certification for batch release, and Annex 19 reference/retention samples.
SimplerQMS supports compliance with EU MDR.
SimplerQMS supports compliance with EU IVDR.
SimplerQMS empowers life science organizations to meet UK MDR requirements.
SimplerQMS facilitates adherence to ISO 14971:2019.
SimplerQMS supports compliance with IEC 60601.
SimplerQMS supports alignment with IEC 62304.
SimplerQMS provides functionality aligned with ISO 1518:2022.
SimplerQMS supports compliance with ISO 16085:2021.
SimplerQMS aligns with pharmaceutical quality systems requirements per ICH Q10.
SimplerQMS supports risk management per ICH Q9.
SimplerQMS supports compliance per ICH Q8.
SimplerQMS supports compliance with PIC/S GMP (Part 1 – Medicinal Products).
SimplerQMS meets ISPE GAMP 5 guidelines, including Annex D1, Section 3 and Annex M3.
SimplerQMS supports compliance with ISO 9001:2015.
SimplerQMS applies ISO 90003:2018 best practices.
SimplerQMS follows ISO/IEC 27002:2022 guidance.
SimplerQMS supports alignment with GDPR (EU).
HIPAA
SimplerQMS supports alignment with HIPAA (US).
How Is the SimplerQMS Software Validated?
SimplerQMS is delivered in a validated state and maintains its validated state across software updates using a risk-based approach aligned with ISPE GAMP 5. SimplerQMS provides applicable computer software assurance (CSA) documentation and evidence to support customers operating in regulated life science environments.
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Regulatory criticality assessment
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Risk management
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Validation planning
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Installation qualification (IQ)
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Operational qualification (OQ)
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Performance qualification (PQ)
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Validation reporting
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8
Ongoing revalidation
SimplerQMS Customers
SimplerQMS serves pharmaceutical and biotechnology companies, medical device organizations, clinical and medical laboratories, and contract research organizations (CROs). Customers range from startups to organizations with 500 employees and more.
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Where Are SimplerQMS Customers Located?
SimplerQMS customers are located in 26 countries across the Americas, EMEA, and APAC. The largest customer markets include the United States, Denmark, Sweden, Switzerland, the Netherlands, and the United Kingdom.
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United States
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Denmark
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Sweden
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Switzerland
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Netherlands
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United Kingdom
- Americas
- EMEA
- APAC
What Customers Say About SimplerQMS
See what verified users and life science professionals say about SimplerQMS on independent software review platforms.
‘’SimplerQMS has been an excellent solution for our team. The platform is intuitive and user-friendly, and the implementation process was incredibly smooth. We were able to go live in just 6 weeks…’’
“The ease of use, customizability, and the support given by the technical support team…Very fast in their response.”
‘’SimplerQMS is much better than our previous paper-based QMS system…SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS and is easy to use.’’
“…I have consistently been impressed with its flexibility and range of features. These features have met all my needs in every aspect. The excellent support team further enhances the overall experience.”
“Amazing customer support and help. The system is clearly structured. After the introduction, it is easy to use.”
‘’User-friendly and simple to use. Easy to customize to fit your individual needs.’’
‘’Exceptional customer support! Compliant to 21 CFR Part 11 and ISO 13485:2015.’’
‘’…SimplerQMS offers the bare necessities and is perfect for our needs.’’
Recognized Across Independent Software Review Platforms
SimplerQMS has received recognition across G2, Capterra, Software Advice, and GetApp through customer reviews and platform-specific awards and badges.
Mission, Vision, and Core Values of SimplerQMS
What Is the Mission of SimplerQMS?
The mission of SimplerQMS is to help life science companies work efficiently with their quality and regulatory documentation and achieve compliance with customer and regulatory requirements.
What Is the Vision of SimplerQMS?
The vision of SimplerQMS is to be the preferred QMS software provider for small to mid-sized life science organizations that prioritize high-quality, efficient processes.
What Are the Core Values of SimplerQMS?
The core values of SimplerQMS are Passionate, Helpful, Respectful, Customer Centric, Quality Driven, and Efficient.
Passionate
SimplerQMS encourages employees to always strive to do their best.
Helpful
SimplerQMS encourages employees to be helpful toward both colleagues and customers.
Respectful
SimplerQMS promotes a respectful workplace that embraces inclusivity and fairness.
Customer Centric
SimplerQMS seeks to understand and exceed customer needs, build trust through transparency and dedication, and be easy to work with.
Quality Driven
SimplerQMS delivers high-quality products and processes while adhering to applicable policies, procedures, and regulations.
Efficient
SimplerQMS maintains a continuous improvement mindset and focuses on delivering results.
Sustainability and Social Impact at SimplerQMS
SimplerQMS supports sustainability and social impact through priorities aligned with the United Nations Sustainable Development Goals and its diversity principles.
Good Health and Well-Being
SimplerQMS supports life science companies developing, producing, and delivering safe, effective products.
Decent Work and Economic Growth
SimplerQMS creates employment opportunities and promotes a supportive, equitable workplace.
Responsible Consumption and Production
SimplerQMS promotes reduced resource consumption, recycling, and digital-first processes.
Diversity and Inclusion
SimplerQMS promotes equal opportunities and cultural awareness across its international team.
Careers at SimplerQMS
How Can You Join SimplerQMS?
SimplerQMS offers career opportunities across life sciences, quality management, technology, and customer success. Open positions are published on the SimplerQMS Careers page and LinkedIn.
Explore SimplerQMS CareersFrequently Asked Questions (FAQs) About SimplerQMS
Find answers to common questions about SimplerQMS software, implementation, Customer Success, and integrations.
What Challenges Does SimplerQMS Solve?
SimplerQMS addresses quality management challenges commonly faced by regulated life science organizations, including paper-based documentation, slow review and approval processes, disconnected quality information, limited cross-department visibility, audit preparation, data integrity risks, and increasing documentation workloads as organizations grow.
SimplerQMS helps address these challenges by centralizing quality records, connecting related processes, automating workflows and assignments, and maintaining controlled, traceable quality information within one electronic quality management system.
How Is SimplerQMS Different From Generic QMS Software?
SimplerQMS is purpose-built for regulated life science organizations rather than for general-purpose quality management. SimplerQMS software, workflows, validation approach, implementation services, training, and ongoing Customer Success services are designed around the quality and regulatory needs of life science companies.
The platform supports integrated processes such as document control, training management, CAPA management, change control, deviation/nonconformance management, audit management, risk management, design control, batch records, and other quality activities.
Who Typically Uses SimplerQMS?
SimplerQMS is used by professionals responsible for quality, compliance, technology, product development, and regulated operations within life science organizations.
Typical users include Quality Managers and Quality Assurance specialists, Regulatory Affairs and compliance professionals, IT teams, research and product development teams, and operations personnel.
How Long Does It Take to Implement SimplerQMS?
Core SimplerQMS modules can typically go live in approximately 6–8 weeks, depending on the customer’s readiness, implementation scope, and availability of the required resources.
The onboarding process can include project kick-off, system setup and configuration, training, data import/data migration, validation support, and go-live activities supported by a dedicated implementation team.
What Is Included in the SimplerQMS Customer Success Program?
The SimplerQMS Customer Success Program is included in the subscription and supports customers from initial implementation through ongoing use and expansion of the eQMS.
During onboarding, customers receive support with implementation planning, system configuration, training, data import, validation, and go-live.
Following go-live, ongoing services include a dedicated Customer Success Manager, success planning, ongoing validation, continued training, technical support, audit assistance, QMS templates, new software features, and support for implementing additional modules and capabilities as the organization grows.
What Support Does SimplerQMS Provide After Go-Live?
After go-live, SimplerQMS continues supporting customers through ongoing training, validation, technical support, audit assistance, system optimization, and implementation of additional modules or capabilities.
A dedicated Customer Success Manager works with the customer on adoption, QMS goals, milestones, and continued value from the system.
Can SimplerQMS Work With Existing Microsoft Office Documents?
Can Existing Documents Be Migrated to SimplerQMS?
Yes. Relevant existing documents can be imported into SimplerQMS as part of implementation and routed through the appropriate review and approval processes to establish a controlled documentation baseline.
The exact migration approach depends on the customer’s existing documentation, implementation scope, and quality processes.
SimplerQMS Contact Information
Contact SimplerQMS for general inquiries, sales questions, or customer support.
Denmark Headquarters
SimplerQMS A/S
Nannasgade 28
2200 København, Denmark
Phone: +45 93 90 16 14
CVR: 39039923 · VAT: DK39039923
