Market Insight: Quality Management Systems (QMS) For Life Sciences
12 Dec, 2025
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Executive Summary
Quality is a fundamental component of highly regulated industries, ensuring product safety, consistency and regulatory compliance. Firms in the life sciences sectors – spanning biotechnology, diagnosis, medical devices and pharmaceuticals – all focus on providing products to improve human health. Defects in these products can place the consumer in grave danger through an adverse effect to their health or by failing to identify key trends during patient diagnosis, potentially leading to further illness and – in severe cases – death. Organizations are thus at risk of further consequences such as financial penalties, imprisonment and negative brand reputation. Consequently, firms in these industries operate under stringent regulations to ensure that the products manufactured meet quality standards and remain consistent. This report delves into the regulatory standards that are driving quality management in life sciences sectors, as well as highlighting unique software functionality that can help organizations improve quality processes to meet these rigorous demands.Quality management systems (QMS) optimize compliance, efficiency and workflows across life sciences industries
Complex regulatory standards and best practice stress the need for a robust QMS in life sciences
QMS provide a standardized tool to manage quality-related processes
Both broad and industry-specific QMS platforms address quality management demands in life sciences
Figure 1. Breakdown of industry-specific quality-related standards
Figure 2. Use of tools to manage quality processes
Figure 3. Breakdown of QMS software vendors for life sciences industries
Aegis
Software, Almac, AmpleLogic, AssurX, Benchmark
Gensuite, ComplianceQuest, Cority, Dassault
Systèmes, Dot
Compliance, Elisa
Industriq, European
Medicines Agency (EMA), Greenlight
Guru, Health
Canada, Hexagon, Honeywell, Ideagen, IEC, Instem, Intelex, International
Council for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH), International
Organization for Standardization (ISO), IQVIA, MasterControl, Omnex
Systems, OpenRegulatory, PSC
Software, PTC, QAD, QT9
Software, Qualio, SAP, Siemens, UL
Solutions, US
Food and Drug Administration (FDA), Veeva
Systems, VLE
Therapeutics, Wismatics, ZenQMS
About the Authors

Zain Idris
Industry Analyst
Zain is an Industry Analyst specializing in EHS digital strategy and corporate spending trends. His research examines how firms are positioning their EHS budgets, considering ...
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Nathan Goldstein
Senior Manager
Nathan is a Senior Manager at Verdantix, specializing in EHS software and the convergence of sustainability, EHS and operational risk. He leads research that helps corporate d...
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