Computer System Validation (CSV) is crucial during technical project delivery, especially in biotechnology, pharmaceuticals, life sciences, and other regulated sectors.

Below are some of the key reasons why CSV is important:

Regulatory Compliance: Many industries, including pharmaceuticals and healthcare, are subject to strict regulatory requirements such as EMA (European Medicines Agency) regulations in Europe and the FDA (Food and Drug Administration) regulations in the United States. These regulations mandate the validation of computer systems used in critical processes to ensure data integrity, product quality, and most importantly, patient safety. Non-compliance can lead to sanctions, product recalls, and reputational damage.

Risk Management: CSV helps identify and mitigate risks associated with computer systems that are critical to the quality and safety of products or processes. By systematically assessing risks and implementing appropriate controls, organisations can minimise the likelihood of system failures, data breaches, and other events that could impact product quality, patient safety or the underlying business operations.

Data Integrity: In regulated industries, ensuring the integrity and accuracy of data generated and maintained by computer systems is vital. CSV involves validating that the system consistently produces accurate and reliable data, performs calculations correctly, and maintains data integrity throughout its lifecycle. This is essential for making informed decisions, ensuring product quality, and meeting regulatory requirements.

Validation Documentation: CSV requires the creation of comprehensive validation documentation, including validation plans, risk assessments, user requirements specifications, functional specifications, test protocols, and validation reports. This documentation serves as evidence of compliance with regulatory requirements and provides a basis for auditing and inspection by regulatory authorities.

Continuous Improvement: CSV is not a one-time activity but rather an ongoing process that continues throughout the lifecycle of the computer system. By periodically reviewing system performance, risks, and regulatory requirements, organisations can identify opportunities for improvement and ensure that validated systems remain compliant and effective over time.

Change Management: During the lifecycle of a computer system, changes may be necessary to address evolving business needs, technological advancements, or regulatory updates. CSV ensures that changes to validated systems are properly evaluated, documented, tested, and approved to prevent unintended consequences and maintain compliance with regulatory requirements.

Overall, computer system validation is essential for ensuring the reliability, integrity, and compliance of computer systems used in critical processes within regulated industries. By following established validation practices and principles, organisations can minimise risks, maintain data integrity, and deliver high-quality products and services to customers while meeting regulatory requirements.