QSR requires that software used for the manufacturers Quality System be subject to design control and validation like any other medical device.
We are about to start using a few different software suites for our quality system. Finally this will consist of the program itself developed by the software manufacturer, and our implementation of it.
So, in this case, does validation mean simply a validation of our implementation of the system, or a validation of the system as a whole?
What does the system do exactly?, considering it is part of your overall quality system yes the implementation and the functionality of the system will have to be validated fully.
No point validating the implementation if you can’t prove that the system functions correctly (consistently and accurately each time)