DELRAY BEACH, Fla., June 25, 2026 /PRNewswire/ — According to MarketsandMarkets™, the Quality Management System (QMS) Software Market is projected to grow from USD 11.73 billion in 2026 and to reach USD 20.43 billion by 2031, at a Compound Annual Growth Rate (CAGR) of 11.7% during the forecast period.

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Quality Management System (QMS) Software Market Size & Forecast:

Market Size Available for Years: 2021–2031
2025 Market Size: USD 10.24 billion
2026 Market Size: USD 11.73 billion
2031 Projected Market Size: USD 20.43 billion
CAGR (2026–2031): 11.7%

Quality Management System (QMS) Software Market Trends & Insights:

The rise of regulation enforcement, the increase in quality risk, and the quest for operational excellence are driving the use of Quality Management Systems (QMS).
By solution, the quality analytics & intelligence segment is expected to grow at the highest rate of 16.6% in the Quality Management System Software Market during the forecast period.
By service, professional services will account for the largest market share in the global Quality Management System Software Market.
By organization size, SMEs are expected to grow at the highest rate of 13.6% during the forecast period.
Asia Pacific is growing the fastest in the Quality Management System (QMS) Software Market, driven by factory digitalization, quality standardization initiatives, and rising demand for cloud-native quality management platforms.

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Globally, the Quality Management System (QMS) Software Market is strengthening as manufacturers, life sciences companies, healthcare providers, food & beverage producers, and other regulated organizations expand digital quality management initiatives to support compliance, operational excellence, and product quality improvement. Large-scale deployments across North America, Europe, and Asia Pacific are driving demand for scalable cloud-based quality management system software and enterprise-wide quality management platforms. Organizations are transitioning from paper-based and legacy quality systems to centralized and cloud-native QMS software architectures that enable connected quality processes, quality analytics, and real-time quality visibility. Quality management platforms must support enterprise-wide document control, CAPA management, audit management, supplier quality management, and change control processes while ensuring regulatory compliance and traceability. Increasing regulatory scrutiny and evolving quality standards are accelerating adoption of compliance management, risk management, and automated quality workflows. As digital transformation initiatives expand globally, scalable, secure, and intelligence-driven quality management system software is becoming a foundational component of modern enterprise quality and compliance ecosystems.

By solution type, quality analytics & intelligence is expected to capture the highest CAGR during the forecast period.

Quality analytics & intelligence has emerged as one of the fastest-evolving segments within Quality Management System (QMS) software, enabling organizations to transform quality data into actionable insights that improve compliance, operational performance, product quality, and risk management. As enterprises generate increasing volumes of data from audits, CAPAs, complaints, supplier quality programs, manufacturing operations, inspections, training records, and regulatory activities, organizations are prioritizing advanced quality analytics platforms to gain real-time visibility into quality performance. Modern quality intelligence solutions combine business intelligence, statistical analysis, predictive modeling, machine learning, and artificial intelligence to identify trends, detect anomalies, monitor quality KPIs, and support data-driven quality decisions. Integration across enterprise systems is enabling organizations to establish connected quality ecosystems that provide a comprehensive view of quality performance throughout the product lifecycle.

The market is increasingly shifting from descriptive reporting toward predictive and prescriptive quality intelligence. Advanced QMS platforms now incorporate AI copilots, natural language querying, automated quality insights, digital quality twins, and predictive risk analytics that enable quality teams to anticipate issues before they affect operations or compliance. According to IBM, in June 2025, IBM expanded enterprise deployment capabilities for watsonx AI solutions, supporting large-scale AI-driven analytics and operational intelligence initiatives across regulated industries. Such developments are accelerating the adoption of intelligent quality management systems capable of continuously learning from quality data and recommending proactive actions. For emerging vendors and solution providers, future opportunities will center on delivering AI-native quality analytics platforms that combine predictive quality monitoring, autonomous insights generation, and real-time decision intelligence to support next-generation quality management strategies.

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By deployment mode, the cloud-based segment is expected to have the largest market share.

By deployment mode, the cloud-based segment is expected to hold the largest share of the Quality Management System (QMS) Software Market during the forecast period due to increasing demand for scalable, compliant, and enterprise-wide quality management platforms. Organizations across life sciences, manufacturing, healthcare, food and beverage, and aerospace are replacing legacy on-premises systems with cloud-based QMS software to streamline document control, CAPA management, audit management, supplier quality management, and change control processes across geographically distributed operations. Cloud deployment enables faster implementation, lower infrastructure costs, seamless software updates, and real-time access to quality data, making it particularly attractive for organizations pursuing digital quality transformation initiatives. Recent developments further reinforce this trend. In February 2025, iBase-t expanded its cloud-native Solumina EQMS platform to support connected quality and manufacturing operations, while MasterControl continued advancing cloud-based quality and manufacturing capabilities for regulated industries. Veeva Systems further strengthened its cloud-delivered Vault Quality Suite with enhanced connected quality workflows and unified quality data management. As organizations increasingly prioritize AI-powered quality analytics, regulatory compliance, remote collaboration, and integration with ERP, MES, and PLM systems, cloud-based quality management system software is becoming the preferred foundation for modern enterprise quality management.

North America to lead the market.

North America remains the most mature and compliance-driven market for Quality Management System (QMS) software, supported by stringent regulatory oversight, advanced manufacturing ecosystems, and rapid digital transformation across life sciences, medical devices, aerospace, automotive, and food & beverage industries. For QMS vendors, the region is attractive because organizations are moving beyond basic compliance management toward enterprise-wide quality intelligence, connecting quality, manufacturing, supplier, and risk management processes on a unified platform. Regulatory pressure continues to be a major adoption driver. According to FDA records and industry analyses of FDA enforcement activity, documentation control, data integrity, corrective and preventive actions (CAPA), and quality procedures remained among the most frequently cited compliance deficiencies during 2025, reinforcing demand for digital QMS platforms that improve audit readiness, traceability, and quality governance.

In addition, AI is becoming a key differentiator, with enterprises increasingly deploying AI-assisted root cause analysis, deviation management, quality event investigation, and preventive action workflows to reduce manual effort and accelerate decision-making. The market is also being shaped by active innovation from North American vendors and evolving regulatory requirements. In January 2026, MasterControl announced the launch of its AI-powered SOP Analyzer, designed to automate document reviews and strengthen compliance management for regulated manufacturers, highlighting the growing integration of AI into quality workflows. In March 2026, MasterControl reported that the company further expanded its AI-first quality platform capabilities, including support for secure AI adoption within regulated quality processes. At the policy level, quality and compliance investments are receiving additional momentum from the FDA’s Quality Management System Regulation (QMSR), which became effective in February 2026 and aligns US medical device quality requirements more closely with international quality standards. For solution providers, this means sustained demand for cloud-based QMS, electronic quality management systems (EQMS), supplier quality management, CAPA automation, and AI-driven quality analytics across North American industries.

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Top Companies in Quality Management System (QMS) Software Market:

The Top Companies in Quality Management System (QMS) Software Market include Hexagon (ETQ) (Sweden), Veeva Systems (US), Siemens (Germany), Honeywell (US), MasterControl (US), PTC (US), SAP (Germany), Oracle (US), Ideagen (US), QAD (US), ComplianceQuest (US), Cority (Canada), SoftExpert (US), Greenlight Guru (US), Fabasoft (Austria), AmpleLogic (India), Ennov (US), Qualio (US), ZenQMS (US), and Omnex (US).

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