Quality assurance of computerised processes is a very broad and formalised concept. Software developers are obliged not only to think critically but also to implement a range of standards, norms, and, as is often the case, legal requirements. Their compliance with the guidelines is usually confirmed by qualification, such as that of Computer Systems Validation (CSV). This article takes a closer look at the definition and main assumptions of CSV.

What is CSV?

To put it simply, CSV is a testing and control process to confirm that a computer system is operating as designed and intended. CSV involves validation and qualification, which are largely about checking that the solution is safe, efficient, and effective and that the data processed with it provide reproducible and truthful results.

Computer System Validation (CSV) is a process used to ensure that computer-based systems used in regulated industries (such as pharmaceuticals, healthcare) operate reliably and securely, while also meeting regulatory requirements. CSV involves a series of activities that verify and document that a computer system performs its intended functions correctly and consistently, adheres to predefined quality standards, and meets regulatory compliance requirements.

How does CSV differ from software testing?

Checking the correct operation of software is a common practice that is currently followed by every IT company, from manufacturers of sophisticated software for regulated industries to publishers of computer games. This means that testing is basically a familiar concept. It may be the case that one initially associates Computer Systems Validation with testing, which is justifiable as there are many similarities between the two. However, CSV is a much more complex process that involves a strongly formalised approach. Each step is documented in a well-defined way, and qualification usually involves checking compliance with both the recipient’s requirements and the legal standards of the industry.

What does CSV involve?

CSV (Computer System Validation) covers a wide range of activities designed to ensure that computer systems used in regulated industries are reliable, secure and compliant with regulatory requirements. This includes:

• Requirements: Precise definition of the functional and non-functional requirements of the system (e.g. security, backup, safety, audit trail, audit trail, records and electronic signatures, etc.).
• Risk assessment: Identifying and evaluating potential risks to the system, such as data integrity, security and regulatory compliance risks.
• System design: Developing detailed design specifications that define how the system will meet specific requirements.
• Installation and configuration: Installing and configuring the system according to the specified design/functional specifications.
• Testing: Conducting various types of tests, such as functional, performance and security tests, to verify that the system works as intended and meets specified quality standards.
• Documentation: Create comprehensive documentation, including validation plans, test protocols, reports, to document compliance with regulatory requirements.
• Change control: Implementing system change management processes, such as change requests, change impact assessments and change validation, to ensure that any changes to the system do not compromise its integrity and compliance.
• Deviation management: Deviation management includes the identification, documentation, assessment, management and reporting of any irregularities or nonconformities associated with the computer system and/or validation process.

Key applications of CSV processes

Computer Systems Validation plays an important role in GxP assumptions. The strongly formalised qualification model is particularly important in regulated industries (especially those that operate in regulated environments where data integrity, reliability, and security are paramount). CSV is often used in the release of solutions for pharmaceutical, biotechnology, and life science companies. Due to its complex testing and control procedures as well as the extensive confirmation of the efficiency and security of the computer system that it provides, the use of CSV is not uncommon in other industries.

CSV – validation in line with risk assessment

Industrial computer systems must guarantee the highest possible level of data security. This is not only about protecting them in the event of an emergency but also thwarting attempts to steal sensitive and secret information. CSV involves a comprehensive risk assessment and testing of the system’s behaviour in possible crisis situations. During qualification, the aim is to determine the impact of sudden equipment failures or power cuts on the state of the database and to define ways in which to prevent unauthorised access.

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