by Market Overview:
Computer system validation is a process to demonstrate and document that the computer system conforms to specified user needs and intended uses and that its functionality, reliability, and data integrity are maintained throughout the system’s life cycle. It helps to manage quality and increase productivity and regulatory compliance.
Market key trends:
One of the major trends in the computer system validation market is the adoption of CTV and a risk-based approach for CSV. The concept of computer system validation has shifted from a traditional approach to a more risk-based and cost-effective validation approach. The risk-based approach focuses on identifying critical aspects and risks associated with the system early in the life cycle. It helps to validate essential functionalities rather than the overall validation of the complete system. This improves productivity and quality with reduced time and cost.
Market key trends:
The computer system validation market is witnessing growth due to increasing regulatory pressure on Life Sciences organizations to comply with various regulatory guidelines for computer system validation. Regulatory bodies such as FDA, and EMA have made computer system validation mandatory at various stages including study design, clinical trial management, batch manufacturing records, quality assurance and control, and other processes. There is also a growing need for improving operational efficiency and reducing costs through digitalization which is driving increased deployment of computer systems across the Life Sciences industry.
The global Computer System Validation Market Size 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.
SWOT Analysis
Strength: Presence of several large players with global reach and capabilities in computer system validation services.
Weakness: High initial costs associated with computer system validation.
Opportunity: Growing digitalization and move towards paperless documentation across the pharmaceutical and biotechnology industries.
Threats: Changing regulatory guidelines may require iterative validation processes.
Key Takeaways
The global Computer System Validation Market is expected to witness high growth, exhibiting a CAGR of 10. over the forecast period, due to increasing regulatory pressure on life sciences firms.
The market size for Computer System Validation was US$ 3.73 Bn in 2023. North America dominated the market due to the stringent regulatory environment and the presence of major pharmaceutical companies in the region.
Key players operating in the computer system validation market are IBM Corporation, Hewlett Packard Enterprise, Infosys Limited, Wipro Limited, Capgemini SE, Cognizant Technology Solutions Corporation, TATA Consultancy Services Limited, Deloitte Touche Tohmatsu Limited, Accenture plc, PAREXEL International Corporation, PwC International Limited, IQVIA Holdings Inc., Tata Technologies Limited, Computer Sciences Corporation (CSC), Eurofins Scientific SE.
Regional analysis: North America held the largest share of the global computer system validation market in 2023 due to stringent regulatory requirements in the region. The market in Asia Pacific is expected to grow at a high CAGR till 2030 with increasing outsourcing of clinical trials and research activities to countries such as China and India.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
