SimplerQMS

SimplerQMS develops quality management software (QMS) built specifically for life science companies. The platform is designed to help organisations in regulated sectors manage documentation, compliance processes, and quality workflows in a single validated system, with the stated goal of boosting productivity by up to 50% and reducing operational costs. The company was founded in 2017, is headquartered in Copenhagen, Denmark, and also maintains offices in San Diego, California and Manila, Philippines. SimplerQMS reports a community of over 15,000 life science professionals and is trusted by more than 5,000 quality professionals worldwide.

The platform serves pharmaceutical and biotechnology companies, medical device manufacturers, clinical and medical laboratories, and contract research, development, and manufacturing organisations (CROs and CDMOs/CMOs). SimplerQMS is itself certified to ISO 13485:2016 and ISO/IEC 27001:2022, and the software is fully validated in accordance with applicable regulatory expectations including ISPE GAMP 5 guidelines.

Industries Served

• Pharmaceutical and Biotechnology: Supports management of GMP-compliant documentation, batch records, training, and CAPA. Aligns with FDA 21 CFR Parts 210–211 and ICH Q10 requirements.
• Medical Devices: Covers design control, risk management, and post-market activities. Supports compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and EU IVDR.
• Clinical and Medical Laboratories: Manages document control, equipment records, and training processes. Supports compliance with ISO 15189 and CLIA requirements.
• Contract Research, Development, and Manufacturing (CROs and CDMOs): Centralises quality documentation, audits, and protocols. Supports GxP requirements and sponsor expectations across outsourced research and manufacturing activities.

QMS Software Modules

• Document Control: Centralises documents and records with version control, electronic signatures, and audit trails.
• Training Management: Automates training assignment and tracking across the organisation.
• Change Control: Manages and tracks changes to processes, documents, and systems.
• Nonconformance Management: Records and manages nonconformances within a traceable workflow.
• CAPA Management: Supports corrective and preventive action processes end to end.
• Complaints Management: Handles customer and product complaints within a regulated framework.
• Audit Management: Plans, executes, and tracks internal and external audits.
• Risk Management: Supports risk identification, assessment, and mitigation activities.
• Equipment Management: Manages equipment records, calibration, and maintenance schedules.
• Supplier Management: Tracks supplier qualification and performance.
• Electronic Batch Records: Manages batch documentation in a GMP-compliant digital format.
• Product Management: Supports product-related quality documentation and lifecycle tracking.

Regulatory and Standards Compliance

• FDA 21 CFR Part 11 (electronic records and signatures)
• FDA 21 CFR Parts 820, 211, 212, and 4
• FDA Data Integrity Guidance (FDA-2018-D-3984)
• ISO 13485:2016 (organisation certified)
• ISO/IEC 27001:2022 (organisation certified)
• ISO 9001:2015, ISO 90003:2018, ISO/IEC 27002:2022
• ISO 14971:2019 (risk management for medical devices)
• IEC 60601, IEC 62304, ISO 1518:2022, ISO 16085:2021
• ICH Q8, ICH Q9, and ICH Q10
• EudraLex Volume 4 GMP (Part 1), Annex 11, Annex 16, and Annex 19
• EU MDR, EU IVDR, and UK MDR
• PIC/S GMP (Part 1)
• ISPE GAMP 5 (including Annex D1, Section 3 and Annex M3)
• CLIA
• GDPR (EU) and HIPAA (US)

Implementation, Support, and Company Background

• SimplerQMS provides end-to-end support covering implementation, validation, training, and ongoing 24/7 customer support.
• The company reports over 30 years of combined life science experience among its team and claims more than 60,000 hours saved on change management across its customer base.
• Co-founder and CEO Jacob Sjørslev Hyrdum previously served as CIO at Ambu, a Danish medical device company, where he oversaw global IT systems including ERP, PLM, CRM, and compliance functions.
• Co-founder and Business Development Director Allan Murphy Bruun previously worked as a Business Systems Consultant at Ambu and also founded Aidcube, a digital therapeutics platform used in hospital rehabilitation programmes.
• The platform holds a 4.6 rating on Capterra and a 4.9 rating on G2.
• SimplerQMS has offices in Denmark (headquarters), the United States (San Diego), and the Philippines (Manila).

SimplerQMS positions itself as a purpose-built, fully validated eQMS platform for life science organisations seeking to consolidate quality processes, maintain regulatory compliance across multiple frameworks, and reduce the administrative burden associated with manual or generic quality management systems.