Computer system validation (CSV) is the process of establishing documented evidence that a computerized system will consistently perform as intended in its operational environment.
CSV is of particular importance to industries requiring high-integrity systems that maintain compliant with current regulations (EU, FDA) under all circumstances.

CSV requires the adoption of rigid standards for verification and validation of deliverables throughout the software life cycle.
It requires a rigorous test methodology with test specifications that are traceable to system requirements.

Software validation is not only employed on new development projects.
Today, more and more systems are built using commercial off-the-shelf software products, software components from other vendors or earlier versions of the same system.
The major objective of software validation is to ensure that the resulting system performs its functions correctly without unintended side effects, and that it meets its safety, security, reliability and auditing requirements.

One issue that often arises in planning a CSV effort is how to ensure the objectivity of the staff performing the validation tasks. Independent validation and verification (IV&V) addresses this issue.
IV&V is the performance of computer system validation tasks by a team that is separate from the software development group.

The starting point of an effective CSV project is a risk assessment (RA).
To manage the risks the assessments will be executed at several moments during the software life cycle.

ps_testware offers training, coaching, consulting, assessments, planning and implementation of CSV programs. We regularly carry out computer system validation projects and consultants have hands-on experience in areas such as GxP and Part 11. Feel free to contact us or download/open the documents on this page for more information.