Europe Quality Management Software Market

The Europe quality management software market in terms of revenue was worth of USD 2078.5 Million in 2020 and is expected to reach USD 2781.8 Million in 2027, growing at a CAGR of 3.71% from 2021 to 2027. The Europe quality management software market is expected to grow at a significant growth rate due to number of driving factors.

Scope of the Report: 

Quality management software (QMS) aims to improve and manage the quality of software. Quality Management system belongs to the set of software including several solutions for document handling, audit management, training, and other quality systems. It is used to substitute the paper-based techniques with automated quality management systems that go along with rigorous regulations and quality specifications. This enhances the product quality, improves the efficiency, and satisfy the customer demands. Quality management software diminishes the risk of quality method failures and reduce costs for huge number of clients throughout a range of industries. QMS also recommends a variety of features like track deviations, develops non-conformances, increases safety and other attributes. Quality management software solutions are accessible in the market which offers a host of functionalities, comprising nonconformance, document control, complaint handling, calibration, and change management. The origins of quality management can be found back to early 1920s when statistical theory was first utilized to product quality control. This concept was further established in Japan.

Covid-19 has shown a negative impact on Europe quality management software market due to various number of factors. The spread of COVID-19 has made quality and compliance management even more critical. It has provided every organization an opportunity to change how they organize their quality processes amid all the restrictions of working from home and social distancing. Continuously increasing spread has impacted the supply chain operations globally. The disrupted supply chain, shortage of labor and resources, and financial difficulties are not the only problems caused by the COVID-19 pandemic situation. Thus, recent issues with the COVID-19 pandemic demonstrate the criticality of integrating the QMS with the organization’s business continuity plan in Europe. As European government mandates were issued causing organizations to shut down, leadership teams kicked their business continuity plans into high gear due to this pandemic. Thus, COVID-19 has adversely impacted on the manufacturing as well as service industry across the globe. The major usage of quality management software (QMS) is in manufacturing industry which is adversely affected by the disease.

The study provides a crucial view of Europe quality management software market by segmenting the market based on Deployment type, industry vertical and region & country level. Based upon Deployment type, Europe quality management software market is segmented into on premise and cloud-based. Based upon industry vertical, the market is segmented into Life Science, Manufacturing, Food & Beverage, Energy & Utilities, and Others. The countries covered in Europe quality management software market are U.K., France, Germany, Italy, and Rest of Europe.

Europe Quality Management Software Market: Market Player Analysis

• Cority
• MasterControl, Inc
• EtQ
• Intelex Technologies
• Pilgrim Quality Solutions
• MetricStream Inc
• Arena Solutions Inc.
• Oracle Corporation
• AssurX, Inc.
• IQMS, Inc.
• Unipoint Software, Inc.
• Ideagen Plc.
• Ennov
• Avanteam
• Veeva
• Bluekango
• Qualios
• Qualishare
• Symalean
• Others

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Market Dynamics

Growing demand for cloud based QMS solutions is one of the key factors driving the growth of Europe quality management, software market. This is due to the oblique scalability and availability which is becoming progressively popular along with all industrial sectors. For instance; Siemen, a German company launched a new solution named CloudConnect in 2020 which is the first step to benefit from the advantages of digitalization. Siemens has the technology that connects the cloud with all kinds of plants. Thus, using a cloud-based system creates operations more effectively and offers greater access to the most valuable data. Thus, the demand for cloud based QMS solutions is increasing due to accessibility and convenient features. In addition, the increasing deployment of applications in healthcare QMS solutions is one of the factors fostering the market growth in this region. The implementation of quality management software is satisfactory enhances resource efficiency, identifying, and reduces medical mistakes while expanding the use of effective care. For example; according to the National Center for Biotechnology Information; the hospitals in European regions including Netherlands, Finland, and Hungary have implemented QMS in hospitals. Many hospitals are implementing quality assurance standards. Quality assurance prevents mistakes and avoids problems while delivering products to the customers. However, the high installation price of quality management software will likely be limiting the market growth to a convinced extent of the quality management software market in this region. In spite of that, the increasing demand for technological advancement and growing artificial intelligence will further contribute to generate the immense opportunities for the further growth of the quality management software market in this region.

The deployment type segment of the European quality management software market is dominated by cloud based segment with the largest market share of XX% in 2020. The industry vertical segment of the Europe quality management software market is dominated by life science segment with the largest market share of 35.20 % in 2020.

Major factors driving the growth of the Europe quality management market are rising number of regulations across different industry verticals, increasing demand and applications of QMS software across various industry sectors, growing awareness about the standards, and rising demand for cloud based QMS solutions in this region. The rising awareness about quality management software is one of the major factors responsible to drive the growth of the Quality Management Software Market in the region.  For example, the United Kingdom-based company, Ideagen plc. launched quality management system software in 2019. It is designed to provide quality-centric culture attentive to nonstop improvement. And, European Medical Device Regulation (EU MDR) to substitute Medical Device Directive in 2020 needs medical companies to meet necessities like device organization and modernizing QMS. Furthermore, its various advantages such as a host of functionalities, comprising nonconformance, document control, and complaint handling of quality management software, are also supplementing the market growth in this region.

Market Trends

A set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization i.e. areas that can impact the organization’s ability to meet customer requirements is nothing but the quality management software (QMS). It helps businesses assess and maintain the quality of produced goods and customer experiences. It is used to define and implement quality specifications based on customer requirements in conformance with industry standards and regulations. It also helps quality professionals generate documentation, perform inspections and report on issues such as defective merchandise or product recalls. Many production managers and Manufacturing and supply companies use this type of software for implementing corrective or preventive actions and optimize product quality and to audit the production process from start to finish avoiding a wide variety of potential hazards & issues and increasing revenue by providing better customer satisfaction.

Some of the major Trends of Europe quality management software market are as follows: 

1. A) ETQ Reliance (EtQ):

ETQ Reliance is a cloud-based quality management solution with a strong focus on environmental health and safety. It is mostly useful for industries that are subject to stringent controls and must be compliant with multiple codes and regulations. it’s most popular verticals include manufacturing, biochemical, food and beverage, aerospace, big pharma, automotive and chemicals. Along with quality management, it also consists of environmental management, health and safety management, operational risk management and sustainability performance management. It is one of the most comprehensive health and safety compliance tools but it doesn’t state which third-party apps with which it’s compatible. When it comes to specific quality control tasks, this ETQ Reliance helps the entire workforce to stay on-brand using all the tools that expect to see from this type of software. These include CAPA, document control to audit management, nonconformance management, production part approval process (PPAP), 21 CFR Part II and supply chain quality management. It is an easy-to-use QMS platform that incorporates about 40 applications to help business owners and managers maintain high standards while driving operational efficiency.

1. B) Arena’s Quality Management System

Arena Company provides product-centric Quality Management System (QMS) which connects quality and product designs into a single, secure system. It helps user to introduce new products to market while ensuring regulatory compliance. This QMS software solution is the clear choice for medical device manufacturers. It connects quality records directly to the product design in a single system and company help user document & track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records and corrective & preventive actions (CAPAs) in context to the entire product record & bill of materials (BOM). It is also used for managing disconnected quality & product systems to create confusion and delays commercialization efforts. With this QMS software, everyone can stay on the same page throughout the new product development & new product introduction process. This software speeds the organization’s product launches while ensuring regulatory compliance with the lowest total cost of ownership (TCO).

1. C) EHSQ Software

This EHSQ is a cloud-based quality management system which works within a broad range of industries containing from pharmaceuticals to food and beverage. Its Continuous improvement is at the forefront of this provider’s strategy with tools to help operators exceed quality standards while saving money & improving efficiency. It joins with a broad range of third-party apps, so user can gather data from all departments and generate reports that help all workers make changes and stick to them. Its reporting capabilities are also impressive with the analytics available such as Occupational Safety and Health Administration (OSHA), Safety incident, nonconformance, insight and custom reporting at the touch of a button. Company’s team at Intelex EHSQ understands that brand consistency is more essential than ever in a customer-driven marketplace. It helps user to move manual processes into the digital space by saving time and labor and also, user can use all the information that user gather to drive intelligent decision-making across every stage of the product life cycle. It includes all the features that had hope to see in a comprehensive QMS, including document control, CAPA, ISO standards management, complaints management, training management, risk management, audit management and compliance management.

1. D) DELMIAworks Quality Management Software (QMS)

This QMS offers industry-specific manufacturing and ERP tools to help operators streamline quality procedures in cost-effective ways. It also helps companies to stay compliant with a range of manufacturing industry standards that include ISO, FDA, 21 CFR Part 11 and TS, in addition to synchronizing with all CRM and MES information. As such, user can tighten up their SPC, RMAs, nonconforming inventory and BOMs to simplify audits and reduce errors. It lets user to track quality across all aspects of user operation using a database that’s integrated with user’s manufacturing, accounting, supply chain management and customer management systems. This means user can generate a wide variety of useful analytics and reports that include financial reports, custom reports, production reports, material staging reports, bank reports, CAR corrective action reports and material exceptions reports. In addition to remaining compliant, operators can define, schedule, oversee, delegate and track corrective action requests & CAPAS for ensuring they’re meeting supplier & customer requirements.

1. E) Digital Quality Management System (QMS) Software

This QMS solution is used by five of the largest regulatory agencies. This QMS is a well-known in the life sciences industry, and among the most widely adopted solutions in the vertical. Current users include several major regulatory agencies and 1,000 enterprises in 30 countries. Its major advantages include; superior connectivity between modules and processes, robust features for collaboration and administration, users report satisfaction with efficient document management features and the newly designed user interface is accessible and intuitive.

1. F) SmartSolve

It is marketed as a comprehensive solution for managing risk, compliance, quality and the supplier chain in the life sciences sector. It is built under the ISO 9001 standard for quality management systems & it provides document management, workflows and process management. Its additional capabilities include features & tools for electronic audits, signatures, analytics and validation. Its advantages are as follows “Extreme” amount of functionality, Change management support and efficient document updates, “Clear and organized” documentation and Administrative dashboards and project management features.

1. G) eQMS Solution

This cloud-based eQMS is designed to help simplify comprehensive quality management at life sciences organizations involved in the development, production, and distribution of pharmaceuticals, medical devices, and biotechnology products. The solution includes all of the tools needed for fast-growing organizations to excel at audits, proactively eliminate defects, and achieve the business benefits of quality-driven growth. It is designed specifically under regulatory requirements including FDA, ISO, and GxP. Software features include document control, training, nonconformances, CAPA, audits, suppliers, complaints, and more. Customers can access flexible, transparent pricing models designed to accommodate the needs of organizations from startup to enterprise.

1. H) TrackWise Software- On-Premises QMS Software

TrackWise QMS software IS designed for organizations that are subject to GMP requirements. Company places the product as a comprehensive QMS solution that designed for increasing visibility & improving organizational efficiency in a competitive market. This software solution offers the potential to assimilate into a complex software ecosystem at enterprise organizations, containing integration with CRM, ERP, laboratory information management (LIMS) and manufacturing execution system (MES) applications. This TrackWise can integrate with user’s CRM, ERP, LIMS and MES systems. It ensures the real-time interoperability among all enterprise systems. The administrations that are looking for a robust solution for enterprise QMS may consider Trackwise. This G2 Crowd user-reported data indicates the majority of Trackwise adopters are at very large organizations and this Trackwise's potential for integration is a significant strength & a requirement since the software's features are not inherently sufficient to obey with ISO 13485 and other regulatory requirements. Its advantages are such as it has wide range of workflows and modules, it is scalable & designed for multi-site implementations, and it is extremely flexible system supports extensive customizations.

Report Analysis	Details
Historical data	2015 - 2020
Forecast Period	2021 - 2027
Market Size in 2020:	USD 2078.5 Million
Base year considered	2020
Forecast Period CAGR %:	3.71 %
Market Size Expected in 2027:	USD 2781.8 Million
Tables, Charts & Figures:	175
Pages	200
Key Players/Companies	Cority,MasterControl, Inc,EtQ,Intelex Technologies,Pilgrim Quality Solutions,MetricStream Inc,Arena Solutions Inc.,Oracle Corporation,AssurX, Inc.,IQMS, Inc.,Unipoint Software, Inc.,Ideagen Plc.,Ennov,Avanteam,Veeva,Bluekango,Qualios,Qualishare,Symalean,Others
Segments Covered	By Deployment Type, By Industry Vertical
Regional Analysis	North America, U.S., Mexico, Canada, Europe, UK, France, Germany, Italy, Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of the Middle East and Africa

Europe Quality Management Software Market: By Deployment Type

• On Premise
• Cloud-Based

Europe Quality Management Software Market: By Industry Vertical

• Life Science
• Manufacturing
• Food & Beverage
• Energy & Utilities
• Others

Europe Quality Management Software Market: Regional Analysis

• Europe
• U.K.
• France
• Germany
• Italy
• Rest of Europe