Computer System Validation Market Analysis

  • Report ID: 5839
  • Published Date: Jan 03, 2025
  • Report Format: PDF, PPT

Computer System Validation Segmentation

Type of Service (Consulting Service, Testing Service, Documentation Service, Training Service, Others)

The documentation service segment predicted to account for 40% share of the global computer system validation market during the forecast period. In computer system validation, documentation services are the key components that encompass the creation and execution of the necessary documentation for completing a successful CSV project. The process of making sure a computerized system performs as intended, consistently and reliably, is known as system validation. A system's compliance with applicable GxP requirements and its ability to monitor the quality of the data it processes are both demonstrated via validation, which involves the production and upkeep of records.

Application (Pharmaceuticals, Biotechnology, Medical Devices, Clinical Research Organizations, Others)

The pharmaceuticals segment is predicted to account for 40% share of the global computer system validation (CSV) market during the forecast period. To manufacture pharmaceutical products such as excipients, biotechnology, Active Pharmaceutical Ingredients (APIs), and more., the pharmaceutical business has to develop a validation strategy that outlines how the equipment, methods, raw materials, and procedures will determine the desired outcomes. CSV inspections and audits by the FDA and other regulatory agencies place a strong emphasis on computerized systems utilized in the pharmaceutical business for the storage, management, or transmission of data about regulatory compliance. Any system needed to create, edit, preserve, or send electronic signatures and electronic records falls under this category. For these systems to be secure and operate as intended, a CSV must be performed as part of the validation process. Furthermore, pharmaceutical companies have also observed a rise in investment in research & development which is also boosting the growth of the computer system validation market. Around 243 billion US dollars were spent on research and development in the pharmaceutical sector worldwide in 2022.

Our in-depth analysis of the global computer system validation market includes the following segments:

     Type of Service

  • Consulting Service
  • Testing Service
  • Documentation Service
  • Training Service
  • Others

     Application

  • Pharmaceuticals
  • Biotechnology
  • Medical Devices
  • Clinical Research Organization
  • Others

Browse key industry insights with market data tables & charts from the report:

Frequently Asked Questions (FAQ)

In the year 2025, the industry size of computer system validation is assessed at USD 4.26 billion.

The computer system validation market size was over USD 3.92 billion in 2024 and is projected to reach USD 14.02 billion by 2037, growing at around 10.3% CAGR during the forecast period i.e., between 2025-2037. The market growth is impelled by growing integration of AI & MI in computer system validation, the rising adoption of cloud computing, and the surge in the adoption of computer system validation by pharmaceutical companies.

North America industry is expected to dominate majority revenue share of 35% by 2037, impelled by rising presence of pharmaceutical companies in this region.

The major players in the market are Hewlett Packard Enterprise Development LP, Wipro Limited, IBM Corporation, Infosys Limited, and others.
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