Central to the software validation process is risk analysis. This is because computer systems are important elements in the way laboratories operate, especially for the management of information.
As presented in this webcast, the first step is to make an inventory of the software used in the laboratory.
The objectives of software validation are, firstly, to ensure that these tools perform correctly; and, secondly, to control them as long as they are in use, allowing changes to be integrated without impacting the systems.
A validation file can then be drawn up and the proofs necessary for this validation will need to be recorded.