Bespoke application without data retention/saving


I do have bespoke application (Cat. 5). This app is not used to retain/save any data - passes data from one system to another.

Would there be a difference in validation process of this application from standard custom application/system validation?



Hi Thomas,

Due to the fact that this is a Cat 5 application the full rigors of validation must apply to this system, ie this system must be validated fully as per intended use which is an important point in my view.

As this application does not retain any electronic records, from what you have said Part 11 does not seem to apply to this system.

So to summarise, yes the system must be validated fully but as far as I can see this application does not seem to record electronic records hence it doesn’t need to be part 11 compliant.