Computer System Validation Guide

The service consists of a thematic workshop and a set of sample documentation that will serve you for the internal validation of your computer systems. During the workshop, legislative requirements for the validation of computer systems are presented, which are applied to the needs of your systems. Within the documentation templates, we will supply URS, DQ, Validation Plan, Risk Assessment Analysis based on Simplified FMEA, IQ, OQ, PQ and Final Validation Report.

Download the presentation from the link below for more theoretical information.

https://www.sukl.cz/file/92424_1_1