Software Validation

There is a need to follow strict documentation with Document Control, SOPs, etc. with their audit histories for them to comply with GxP. As it is a regulatory requirement, we, as software vendor, we have tried to incorporate SOPs and have reviewed and modified them as time has gone by…

In software development, the software quality control is referred in context to validation and verification. The words, verification and validation, are quite same but actually they refer to very distinct activities. The similarity in their meanings starts the confusion.

As per US FDA’s 21 CFR Part 11 compliance requirements, software validation is a key task. And a lot of material is available over the net on this topic. But my take on software validation is something like this…