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Fundamentals of Computerized Systems Validation (CSV) Part 4

Requirements Specification

Quality Assurance - CSV - Software Validation

This is the fourth in a series of posts on general aspects of Computerized Systems Validation (CSV) and is about capturing requirements.


One of the first things to do at the start of a computer validation project is to look at what you would like to achieve with the system(s) you are planning to put in place. It is also not uncommon that this exercise happens in different iterations and takes more time and resources then any other phase in the validation project. Essential is that all stakeholders and the appropriate SMEs are included and that there is a common understanding of what is required.


Often requirements are provided by the software vendors themselves. This is not wrong especially for commercial-off-the-shelf software that require minimal configuration or customization but, in a GxP environment, the regulated company is in the end responsible that the requirements reflect the intended use of the system(s). Requirements should therefore also be driven by the business process rather than the system to-be.


Discussions and interviews or workshops involving participants from different areas are good ways to capture requirements. These should include process and system owners, end users and business process experts. The activity can also be outsourced to a business analyst to observe and analyze business operations. Especially when the analyst is specialized in the business domain this can lead to good quality requirements. It does require a collaborative environment and as noted earlier this could consume a not to be underestimated time and effort.


Requirements specification is one of the first things to do at the start of a validation project and therefore crucial since it determines what system should be delivered at the end of the project. It is of utmost importance that the right stakeholders and expert are included and all have a common understanding of what needs to be delivered. Variations in the understanding usually lead to discussions and changes later on that often consume a lot more time and effort. Requirements should be specific enough to be verifiable for validation. Contact us for a free first consultation session.

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