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Computer System Validation Market to Surpass US$ 7.33 Billion by 2030, Says Coherent Market Insights (CMI)

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CMI

CMI

Unlocking Seamless Compliance: Cutting-edge Computer System Validation Solutions Streamline Regulatory Processes for Enhanced Efficiency and Risk Mitigation in Highly Regulated Industries

Burlingame, June 12, 2023 (GLOBE NEWSWIRE) — According to Coherent Market Insights, global computer system validation market is estimated to be valued at US$ 3.39 billion in 2022 and is expected to exhibit a CAGR of 10.1% during the forecast period (2023-2030).

Analysts’ Views on Global Computer System Validation Market

Increasing adoption of CSV in regulated industries is a key factor propelling growth of the global computer system validation market. The use of computer systems can automate, accelerate and improve the efficiency of quality assurance and production processes. Moreover, they also minimize the risk of human error. In addition, CSV can replace paper records and enable electronic signatures that are legally equivalent to handwritten signatures. Computer system validation is a crucial aspect of regulated industries and is carefully monitored by worldwide health protection bodies such as the MHRA (Medicines and Healthcare Products Regulatory Authority) and USFDA (US Food and Drug Administration). The CSV process makes sure that computer systems generate data that meets specific requirements and consistently perform as intended. Besides, CSV helps companies avoid costly regulatory penalties and reputational damage.

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Key Trends and Analysis of the Global Computer System Validation Market:

Increasing adoption in pharmaceutical companies is expected to foster computer system validation market growth. CSV is not only important for pharmaceutical manufacturers, but it is also a crucial step for distributors of medical devices. For instance, a pharma business that sells any device that is intended for the diagnosis, treatment, or prevention of disease must undergo CSV in order to meet the FDA’s Good Manufacturing Practice (GMP) norms set out in Annex 11. This includes everything from laser scanners and tongue depressors to biotechnology products such as vaccines and therapeutic serums.

Global Computer System Validation Market – Drivers

Growing focus on safety and effective manufacturing process of drugs is propelling computer system validation market growth

In the pharmaceutical industry, a well-planned computerized system validation process helps to build a manufacturing environment in which drugs can be produced that are pure, safe, and effective. Moreover, it is also beneficial in the manufacturing of biologicals, medical devices, and cell-and-tissue products that are consistent, reliable, and reproducible. Hence, the use of CSV help to maintain safety in the drug manufacturing process. Therefore, the growing focus on safe and effective manufacturing process of drugs is boosting CSV market growth.

Increasing adoption in regulatory industries is augmenting market growth

The global computer system validation market is witnessing strong growth on the account of growing demand for technology in regulated sectors such as biotechnology, pharmaceuticals, and healthcare. Moreover, the pharma sector is highly dependent on computers for clinical trials, research and development activities, production, and distribution processes. Hence, computer system validation (CSV) is important in ensuring compliance with strict regulations in the pharma industry. Furthermore, CSV also allows companies to meet global healthcare protection organizations inspections.

Computer System Validation (CSV) Market Report Coverage

Report Coverage

Details

Base Year:

2022

 

Market Size in 2022:

US$ 3.39 Bn

Historical Data for:

2017 to 2021

Forecast Period:

2023 – 2030

Forecast Period 2023 to 2030 CAGR:

10.1%

2030 Value Projection:

US$ 7.33 Bn

Geographies covered:

  • North America: U.S. and Canada

  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe

  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific

  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America

  • Middle East and Africa: GCC Countries, Israel, Rest of Middle East, South Africa, North Africa, and Central Africa

Segments covered:

  • By Type Of Service: Consulting services, Testing services, Documentation services, Training services, Other services

  • By End User Industry: Pharmaceuticals, Biotechnology, Medical devices, Clinical research organizations (CROs), Other regulated industries

Companies covered:

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

Growth Drivers:

  • Increasing Complexity of Computer Systems

  • Risk Mitigation and Quality Assurance

  • Data Integrity and Security

  • Globalization and Outsourcing

Restraints & Challenges:

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Global Computer System Validation Market – Restrain

Complexity associated with the use of computer system validation

Complexity associated with the use of computer system validation is expected to hamper the market growth. It is a complex task that requires expertise in the field. Additionally, it is important to have the support of experts in the field for strategy planning, removing irrelevant aspects and/or modifying essential ones, test selection and defining acceptance criteria. Moreover, the process is time-consuming and requires specialized expertise, resources and documentation which is again hindering market growth.

Global Computer System Validation Market – Opportunities

Increasing adoption of automation in manufacturing sector is expected to bring bright market opportunities

Computer system validation is not only required for regulated environments, but also for all businesses that use computers. For example, the US FDA requires pharmaceutical manufacturers to validate their computer systems as part of Good Manufacturing Practices (GMP). The EU also has a set of GxP guidelines that need computer systems to be validated. The goal of validation is to verify that the computer systems and software are accurate, reliable, and secure in a GxP environment. This is accomplished through a series of steps, which are described in the Good Automated Manufacturing Practices (GAMP) guidance. Hence, increasing automation in manufacturing sector is projected to provide potential market growth opportunities in the near future.

Global Computer System Validation Market Key Developments

In June 2023, Critical Manufacturing, a subsidiary of ASM Pacific Technology, and Dataworks, a provider of advanced software solutions and validation services to the life sciences and biotechnology sector, announced a strategic partnership to help ensure easier compliance and minimize the time and cost associated with validation in regulated industries.

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Key Market Takeaways:

Global computer system validation market is expected to exhibit a CAGR of 10.1% during the forecast period. The computer system validation market is experiencing significant growth owing to the growth need for regulated industries in order to maintain and enhance data quality. Regulated environments, such as medical devices, healthcare, and pharmaceutical companies, rely on computer systems to achieve an effective manufacturing process and record product data. This data is majorly used to meet regulatory compliance requirements and offer assurance that processes are consistent, correct, and traceable. Hence, computer system validation is crucial to ensuring that the end product meets consumer expectations.

On the basis of type of services, documentation services is expected to hold a dominant position over the forecast period. Documentation services in computer system validation are the ket steps that enbale the development and implementation of the essential documentation to carry out a successful CSV project. The validation of a computer system is the process that ensures that a computerized system does what it is designed to do, in a consistent and reproducible manner. Validation includes the creation and maintenance of records mandatory for monitoring the quality of the data processed by a system as well as demonstrating that the system is compliant with GxP applicable regulations.

On the basis of end user industry, pharmaceutical industry is expected to hold a dominant position. In the pharmaceutical industry, computerized systems that are used to store, manage or transmit data relating to regulatory compliance are a key focus of CSV inspections and audits by FDA and other regulatory agencies. These systems include any system that is required to generate, modify, maintain or transmit electronic signatures, and electronic records. These systems must be validated by performing a CSV to demonstrate that the systems are functioning as intended and are secure.

On the basis of region, North America is expected to hold a dominant position over the forecast period, due to strong presence of pharmaceutical companies in the region. Moreover, presence of strict regulatory environment and increasing emphasis on data integrity have further drive the demand for CSV in the region.

Competitive Landscape:

Key players operating in the global computer system validation market include 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

Market Segmentation:

  • Global Computer System Validation (CSV) Market, By Type of service:

    • Consulting services

    • Testing services

    • Documentation services

    • Training services

    • Other services

  • Global Computer System Validation (CSV) market, By End-user industry:

  • Global Computer System Validation (CSV) Market, By Region:

    • North America

    • Latin America

      • By Country:

        • Brazil

        • Mexico

        • Argentina

        • Rest of Latin America

    • Europe

      • By Country:

        • Germany

        • U.K.

        • France

        • Italy

        • Spain

        • Russia

        • Rest of Europe

    • Asia Pacific

      • By Country

        • China

        • India

        • Japan

        • Australia

        • South Korea

        • ASEAN

        • Rest of Asia Pacific

    • Middle East

      • By Country:

        • GCC

        • Israel

        • Rest of Middle East

    • Africa

      • By Country/Region:

        • South Africa

        • Central Africa

        • North Africa

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About Us:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients.

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