Quality management software system helps organizations to inter-correlate all departments, which crucial for regulated or ISO-compliant organizations. Employees from concerned departments can provide their feedback, which in turn removes the communication gap across the organizations and helps to increase efficiency and accuracy of the production process. Furthermore, compliant management software helps an organization to restructure its complaint handling process and reduce the complexity of the end-to-end process right from complaints submission to its resolution. With careful selection of quality and compliance management solutions as per their requirement, users can get significant benefits including an increase in quality, productivity, market share as well as a reduction in time to market their products and resource costs.

Market Statistics:

The global quality and compliance management solution market is expected to surpass US$ 40,215.9 Mn in terms of value by the end of 2028.

Market Driver

Increasing regulatory complexity in the life sciences industry is expected to propel the global quality and compliance management solution market during the forecast period. Numerous regional healthcare authorities have started implementing standards that are specific to regions that can incur an additional cost. Efficiently managing these regulatory requirements can aid manufacturers in surviving in competitive environments. Thus, manufacturers in the life sciences industry find this quality compliance software a suitable option, in order to reduce the risk of losing market share. This, in turn, an increase in demand for QMS solutions worldwide.

Market Opportunity

Data analytics in quality management can present lucrative growth opportunities. Implementation of data analytics with quality and compliance management solutions is a major trend in the market. Quality management solution vendors are aware of the role of big data analytics & predictive analytics in risk management and regarding the benefits offered by data visibility in terms of compliance. Therefore, various quality management solution providers such as Pilgrim Quality Solutions' “SmartSolve Business Intelligence”, Sparta Systems, Inc.’s TrackWise QualityView, and others are focused on developing and introducing quality management analytics in the market.

Global Quality and Compliance Management Solution Market: Recent Developments

  • Major companies in the market are focused on product launches, in order to gain a competitive edge in the market. For instance, in January 2019, EtQ introduced ETQ Reliance 2019, a QMS solution.
  • In August 2020, MasterControl, Inc. launched its new solution, MasterControl Manufacturing Excellence, to enhance manufacturing operations by driving efficiency and quality. The new solution would enable manufacturers to create dynamic connections among enterprise systems, processes, data sources, and people for a holistic view of production and quality data.

Market Restraint

High initial capital investment of QSM solutions is expected to hinder the global quality and compliance management solution market growth over the forecast period. The initial investment for quality and compliance management solutions is significantly high. Many small and medium-sized enterprises cannot afford high initial investment and hence they are hesitant towards the adoption of QSM.

Global Quality and Compliance Management Solution Market - Impact of Coronavirus (Covid-19) Pandemic

The COVID-19 outbreak has impacted numerous industrial verticals and markets, rendering a sharp decline in growth. Following the outbreak in December 2019, many countries started closing down international borders, leading to temporary disruption in major economic activities. This has disrupted major economic activities, resulting in major decline in the global smart mining market. Besides, there are strict regulations on physical distancing, which has temporarily suspended mining activities in different parts of the world. However, with rollout of vaccines and declining spread of the virus, the market players are optimistic about the potential growth of the market. Moreover, many countries have started relaxing regulations on international travel, which can aid in growth of the market.

To know the latest trends and insights prevalent in the Global Quality and Compliance Management Solution Market, click the link below:


Key Takeaways:

  • The global quality and compliance management solution market was valued at US$ 18,504.5 Mn in 2020 and is forecast to reach a value of US$ 40,215.9 Mn by 2028 at a CAGR of 9.9% between 2021 and 2028. Seamless integration with existing enterprise systems is expected to drive growth of the global quality and compliance management solution market during the forecast period.
  • The Healthcare & Life Science Segment held dominant position in the market and accounted for 1% share in the global quality and compliance management market in 2020. The segment is expected to reach US$ 28,432.7 Million in 2028, owing to QMS is increasingly gaining importance among companies to help meet critical objectives such as compliance with industry regulations, avoidance of potential product liability lawsuits, and customer retention.

Market Trends

Japan is the hub for automotive manufacturing companies. Increasing the need to streamline design and manufacturing processes and ensure quality and regulatory compliance in this industry is resulting in automotive players shifting focus on implementing quality and compliance solutions. For instance, in April 2016, Toshiba Machine Company, Ltd. selected Aras’s Innovator enterprise software with the objective to enhance product quality and streamline its manufacturing processes as the company continues to expand internationally.

Asia Pacific is becoming the first choice among prominent players in the global quality and compliance management solutions market to establish their presence, with an objective of leverage increasing business opportunities from the rapidly growing life sciences and automobile industries in the region. For instance, in December 2014, MasterControl, Inc. partnered with PharmaBioSolutions, a China-based consultancy specializing in the life science industry. Through this partnership program, the company is able to distribute its software products in the market in China.

Competitive Section

Key players operating in the global quality and compliance management solution market are Pilgrim Quality Solutions, Sparta Systems, Inc., MasterControl, Inc., SAP, Aras, Oracle, Arena Solutions, Inc., IQS, Inc., and EtQ.


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