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Master validation plan

Author:
WWARN

To provide instruction to all parties involved in system validation of computer equipment/servers/software that will be used during a clinical study. This document will list and document the objectives for all parties responsible for validation of computer equipment and software used in the production environment to create, modify, maintain, archive, retrieve or transmit clinical data, and the activities required to ensure that the computer systems comply with international regulations. Validation is not required in any test or development environment. 

doc
14 April 2018
v1.0
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1005.5 KB