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Standard Operating Procedures

Computerized Systems Validation (CSV) Part 10

Quality Assurance - CSV - Software Validation - SDLC

Once a system is validated it needs to be maintained and kept in a validated state. In this last post on the Fundamentals of Computerized Systems Validation, we will discuss what is required to keep a system in a controlled validated state.

End User Work Instructions

Users need to have written instructions on how to work with a system and especially on what they can and cannot do. Ideally, a draft of this procedure would already be available before acceptance testing where it would function as a source of input for the test scripts to be executed.


One or more procedures should be available for the technical maintenance and support of the system by the technical support team. These should include

- how to maintain access to the system

- incident and problem management

- backup and restore

- monitoring


One or more procedures should be in place for quality management purposes e.g.

- change and configuration management

- periodic review


Validating a system is only half the work. Once it is release into production the operational phase starts in which the system needs to be maintained according to written procedures. These practices are common in quality as well as information security management in order to maintain data integrity and accessibility. Contact us for a free first consultation session.

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