Computer system validation

Computer system validation is an essential aspect to using technology in clinical research. The system must be shown to be compliant and operational for its intended use by the user of the system – typically the company that has purchased and is using it. Validation of the system should be an integral part of planning for the introduction of new system. And it will be a persistent part of system maintenance until the system is retired from use. For this reason, the business and IT teams who will be involved with the new system must include valdiation as a core part of their activities involving the system. 

The purpose of validation is to ensure that the system used in clinical research collects, manages, reports on, and transfers the data in its control in an accurate and reliable manner. It verifies that all changes to a data object, starting with its initial save in the system database, is documented and track such that a neutral observer could take the record of changes, also referred to as an audit trail, recreate the history of that datapoint. This is critical for both data quality and patient safety, as it imperative that a datapoint undergoes no unrecorded changes, either by the system or a user. 

Along with capturing all data changes accurately, validation ensures that all users who access the system use a unique user ID and have been given permission to use the system. The verification of the system security ensures that only one person has access to one user account. It also ensures that unauthorized individuals are prevented from accessing the system