Pharmaceutical Quality Management Software (QMS) Market

The global pharmaceutical quality management software (QMS) market is projected to reach USD 2.98 billion by 2030 from USD 1.59 billion in 2025, at a high CAGR of 13.3% during the forecast period. The pharmaceutical quality management software market is experiencing strong growth, driven by increasing regulatory requirements, rising complexity in drug development and clinical trials, and the broader shift toward digital transformation in the industry. Companies are adopting these solutions to streamline documentation, improve compliance, and reduce risks associated with manual processes. Cloud-based platforms are gaining traction due to their flexibility, scalability, and lower upfront costs compared to traditional systems, while advanced features like automation, analytics, and real-time dashboards are further enhancing adoption. As pharmaceutical and biotech companies face pressure to accelerate time-to-market while maintaining high quality and safety standards, the demand for integrated quality management systems continues to expand across research, manufacturing, clinical, and regulatory functions.

Two key strategies are propelling growth in the pharmaceutical quality management software market: continuous technological advancements and strategic public-private partnerships. On the innovation front, companies are enhancing AI-integrated solutions, automation for predictive quality analytics and real time issue detection. For example, in April 2024, Veeva systems launched Veeva AI Partner Program provides partners with the advanced technology and support needed to integrate Generative AI (GenAI) solutions seamlessly with Veeva Vault applications. On the collaboration front, pharmaceutical & biotechnology companies are increasingly partnering to expand pharmaceutical quality management software infrastructure and reach. A notable instance is the July 2024 Neuraxpharm partnered with Veeva to implement Vault QualityDocs and Vault Training, streamlining quality management and compliance across 100+ CDMOs, enabling standardized, efficient collaboration and high manufacturing quality.

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Prominent players in the market include Veeva Systems Inc. (US), MasterControl Solutions, Inc. (US), Honeywell International Inc. (US), IQVIA (US), Qualio, Inc. (US), Hexagon AB (Sweden), AssurX, Inc. (US), QT9 Software (US), Dassault Systèmes (France), ComplianceQuest (US), Ideagen (UK), SoftExpert (Brazil), Instem (UK), Intelex Technologies (Canada), Intellect, Inc. (US), AmpleLogic (India).

Veeva Systems Inc. (Veeva) is a provider of cloud-based software solutions tailored to the global life sciences industry, focusing on pharmaceutical operations, including quality management systems (QMS). The company has served over 1,000 customers, including top pharmaceutical companies. Veeva addresses critical needs like CAPA, change control, and batch release, driving operational efficiency and regulatory compliance. Veeva’s flagship offering in the pharmaceutical QMS market is Veeva Quality Cloud, a comprehensive suite built on the Vault Platform, designed to streamline and unify quality processes across the product lifecycle. This suite addresses the industry’s stringent regulatory requirements, such as those from the FDA, EMA, and other global bodies, while enhancing collaboration and visibility across quality, manufacturing, and supply chain operations.

MasterControl Solutions, Inc. (MasterControl) provides a, cloud-based Quality Management System (QMS) specifically designed for the pharmaceutical industry, enabling companies to streamline compliance, improve product quality, and accelerate time-to-market. The platform integrates critical quality processes including document control, training management, quality event management, audit management, supplier management, and risk management, into a unified, closed-loop system. The AI-powered automation, MasterControl reduces manual tasks, predicts potential quality issues, and provides actionable insights, allowing teams to focus on innovation rather than paperwork. Its system ensures regulatory compliance with FDA and ISO standards, supports flexible workflows, and facilitates seamless collaboration across departments and suppliers.

Honeywell International Inc. (Honeywell) offers a comprehensive suite of Quality Management System (QMS) solutions specifically designed for the pharmaceutical industry, designed to enhance compliance, operational efficiency, and product quality throughout the manufacturing lifecycle. Its offerings include cloud-based platforms like TrackWise Digital for enterprise-wide quality management, TrackWise Manufacturing for AI-assisted integration of digital and physical manufacturing processes, Honeywell Forge Life Sciences for IoT-enabled operational optimization, and Honeywell Quality Management Review (HQMR) for consolidated, actionable insights across sites. These solutions support diverse pharmaceutical applications, including biotechnology, biopharma, medical devices, and cell and gene therapy, ensuring adherence to regulatory standards while streamlining complex workflows. The company provides pharma QMS solutions through industrial automation segment.

Market Ranking

The pharmaceutical quality management software market have many key players such as Veeva Systems Inc., Honeywell international Inc., IQVIA and others. Veeva Systems has established a strong presence through its Quality Management System, manages core quality processes like deviations, CAPA, audits, change control, and supplier quality in a GxP-compliant workflow. Honeywell offers TrackWise Manufacturing for AI-assisted integration of digital and physical manufacturing processes. IQVIA offera SmartSolveQMS platform for life sciences integrating quality, regulatory, and supplier management. Powered by AI and analytics to enhance compliance and efficiency. MasterControl Solutions, Inc. QMS suite (“Quality Excellence”) that automates and integrates many quality-process functions: document control, CAPA (corrective & preventive action), change control, training management, audits, nonconformance, customer complaints, etc. Dassault Systèmes describes  “Quality Management System (QMS) solutions” as part of their PLM / lifecycle management portfolio. BIOVIA QUMAS EQMS (under Dassault’s BIOVIA brand) which is a cloud-based enterprise QMS for regulatory/quality and process management.

Related Reports:

Pharmaceutical Quality Management Software (QMS) Market by Process (Clinical Trial, Regulatory, Manufacturing, Commercialization), Application (eSOP, CAPA, Compliance), Size (Large, Small), End User (pharma, biotech, CRO), Region - Global Forecast to 2030

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