Computer system validation is a process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specification and quality attributes. It ensures the valid operation of computer systems during the entire lifecycle. The validation process allows companies to meet regulatory compliance obligations and make improvements in production and quality control.
The global Computer System Validation Market is estimated to be valued at US$ 3.73 Bn in 2023 and is expected to exhibit a CAGR of 10% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market key trends:
Increased outsourcing of computer system validation processes is driving the market growth. Large pharmaceutical and biotechnology companies are outsourcing validation activities to specialized Contract Research Organizations (CROs) and Contract Validation Organizations (CVOs) to improve efficiency and compliance. These outsourcing vendors offer validation lifecycle management, custom validation plans, validation tools, documentation and reports. They also handle software configuration management, training and project oversight. This trend is expected to continue as companies focus on their core competencies and rely on expert third-party service providers for computer system validation processes.
Segment Analysis
The global computer system validation market is segmented by product, application and end user. The product segment is further divided into software and services. The services sub segment dominates the market as they assist in the overall validation process through services like project management, training and education, and infrastructure validation. Their demand is high due to the rising need to ensure regulatory compliance.
Key Takeaways
The Global Computer System Validation Market Share is expected to witness high growth over the forecast period of 2023 to 2030. The global Computer System Validation Market is estimated to be valued at US$ 3.73 Bn in 2023 and is expected to exhibit a CAGR of 10% over the forecast period 2023 to 2030.
Regional analysis indicates that North America dominates the market currently due to stringent regulatory norms and increasing adoption of CSV practices across verticals like healthcare and pharmaceutical industries in the region. The Asia Pacific region is expected to grow at the fastest rate led by growth in pharmaceutical manufacturing in countries like India, China and Japan.
Key players operating in the computer system validation market are SAP SE,Oracle Corporation,IBM Corporation,Microsoft Corporation,SAS Institute Inc.,Infor,JDA Software,TraceLink,GS1,Owens & Minor. The global computer system validation market is consolidated in nature with leading players like SAP SE and Oracle Corporation holding major market share.
Note:
Source: Coherent Market Insights, Public sources, Desk research
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