Validation of a software Implementation

MEDICAL DEVICE 21 CFR PART 820 (The Regulations)
#1

Dear Forum,

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?

regards
t.

#2

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)

#3

One system is for registering customer complaints, corrective and preventive action as well as holding parts of the Device History Record.

The other system is a document management system keeping all design documents and project documents under version control.

In both systems such things as workflows, what data being entered etc. are all implemented by ourselves.

regards
t.

#4

Sounds like the Pilgrim SmartSolve system!

Yes this is a most critical application to your organisation, it must be fully validated, once all of the workflows have been decided.

This is a big validation be careful and plan to well.

Regards

#5

Yes it does sound like Pilgrim Software solution

#6

Implementation will require IQ, OQ and PQ validation