Validation of computerised systems requires careful planning to identify the set of validation activities required from initial design through to implementation use and final decommissioning. In practice it can be impossible to validate existing systems where initial design requirements are no longer available or appropriate activities were not performed or documented as the system was designed and implemented. The forthcomming posts in this topic describe the validation activities appropriate to a new system.
However, these life-cycle requirements should be considered when attempting retrospective validation of existing systems. The validation life-cycle activities and their order should be documented in a validation plan. A description of each phase of the life-cycle validation activities will be presented in the forthcomming posts as a sequential process, however certain activities may overlap or be combined. The validation plan should define such overlaps and amalgamations.
All validation activities should be carried out in a safe and secure manner, observing local safety procedures and requirements. A number of key issues should be addressed as soon as reasonably practical. Examples include procurement (supplier capability), regulatory expectations for electronic records/signatures, data integrity, user security, and hand-over issues such as advance knowledge of operation and support requirements.
Generic validation life-cycle will be presented in the forthcomming postes. The application of the life-cycle will vary as appropriate to the type of computerised system being validated. And also the forthcomming posts address how to approach the validation of laboratory systems, control systems, desktop (end-user) applications, IT systems, IT infrastructure and software tools.