Computer system validation (CSV) is essential in today's technology-driven world, where computer systems are the backbone of numerous industries, e.g., pharmaceutical, healthcare, and finance, supporting critical operations or data management. The CSV process includes several different phases, such as planning, testing, documentation, and maintenance. However, the crucial aspect of CSV is establishing System or User Requirements.  

Definition of System and User Requirements and Categorization 

System or User Requirements are the specific requirements that a computer system or software must meet to be considered validated. Those criteria need to be considered in the validation plan and additional requirement specifications and are effective for the entire life cycle of a computer system. They help life sciences organizations and stakeholders to ensure that their computer systems are prepared and ready for the intended purpose while meeting the required quality standards. 

Requirements can be divided into three different categories, such as  

1. Functional requirements - describing what the computer system should do. 

2. Non-functional requirements - describing how the computer system should work. This may include performance expectations, data security measures, and user interface specifications.

3. Compliance with regulatory requirements - ensuring that the computer system complies with applicable regulatory standards that apply to your industry and country. 

How to Formulate System and User Requirements 

Requirements should be formulated in a clear, concise, and measurable way. They should also be unambiguous, i.e., they should not leave any room for interpretation. 

When formulating them, it is helpful to consider the following steps: 

  1. Definition: Define the above-mentioned functional and non-functional requirements of your system 

  2. Regulatory Compliance: Become aware of the relevant regulatory standards you need to comply with. Ensure that your requirements align with these regulations. 

  3. Risk Assessment: Conduct a risk analysis to identify potential vulnerabilities. Use this information to establish additional requirements that mitigate the risk.  

  4. Testing Protocols: The extent of the testing and planning phase should be proportional to the complexity and the risk of the project/system. Develop testing protocols that outline the procedures for validating the system. This can include test cases, test scripts, and expected outcomes. 

  5. Documentation Standards: Define the documentation standards for recording validation activities. Ensure that all testing and verification results are documented in a clear and organized manner. 

  6. Review and Approval: Finally, all the requirements need to be reviewed and approved by relevant stakeholders, such as quality assurance teams, regulatory affairs, and IT professionals.

Reviewing System and User Requirements 

Make sure your requirements are reviewed on a regular base to ensure that they are still up-to-date and relevant. System and user requirements are an important part of the CSV process. They help ensure that computer systems meet the needs of their users and stakeholders while protecting the security and integrity of data. In an era where digitization and technology are an integral part of daily business operations, these requirements are essential for maintaining regulatory compliance, data trust, and system reliability. 

All these aspects are part of EXTEDO’s Computer System Validation Services to support our clients by validating the computer systems in a robust manner. If you would like to get more information about this service, have a look at our website: Validation Services | EXTEDO  


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