Quality System Database Validation - FDA's General Principles of Software Validation

[Weiner Dog]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

Hmm- I guess that the owner just needs a little nudge from FDA or a Notified Body. Don't you just love reactive, not proactive managers? For them, the borrom line is $$$ not a TQS!

 

[Tarrahb1]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

Its helping me now

 

[allendavid]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

still confusing. if I want to validate one business software, IQ, OQ, PQ are covered, is it ok?

 

[Jimmy Arctic]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

IP and OQ should get you most of the way there but PQ needs to show the system if fit for YOUR purpose, and not just some general purpose. If it does then I think the suite of qualifications should be evidence enough.

 

[Weiner Dog]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

If part of a medical device, don't forget PPQ as well.

 

[Weeder]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

Hi Roger,

I read your original post and it mirrors the kind of situation I am facing as well. However, my dileema is validating Microsoft Word. After reading FDA requirements it seems like even when you use print copies as the official record, you still need to validate the software because part of the process require using Word to carry out the requirement until the record is printed. So the questionis how do you validate Word? The typewriter arguement is not acceptable since the record resides in Word and it is updated periodically until the CAPA or complaint or service order or whatever you are maintaining in Word is printed.

There is nothing on the internet regarding this (as far as my search goes) although there is some on spreadheet and database validation.

Do you have any suggestions? or steps that need to be taken to validate a word processing pakage?

 

[c.mitch]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

Hi Weeder,
Do you use word "as is" or did you added macros or customized forms (either yours or 3rd party) ?
If you added macros or forms, you have to validate them.
If you use word "as is" I think that there's no need to validate it. It would be like wanting to validate paper and pen.
Regards
Mitch.

 

[jshipley72]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

I have been out of the Medical world for a bit - however I recall that one would not need to validate a system, for example excel, if used for compiling data as long as that information is printed and signed then the system itself doesn't require validation.

Can anyone tell me where I can find that detail in the FDA guidelines?

 

[Al Rosen]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

There is a software validation guidance document that you can find in the FDA database here.

 

[jshipley72]

Re: Quality System Database Validation - FDA's General Principles of Software Validat

Thank you for the reference:

A little more detail on what I am trying to find exactly:

We measure product on a CMM (Which of course is calibrated) the data is then manually keyed onto a spreadhsheet. The spreadsheet is reviewed, approved and signed. Then added to the appropriate DHR.

My questions is this: Do we have to do a software validation on the CMM? I thought that software did not need to be validated if you were not using it to make the decision on data. If the decision was made via a review and signed (meaning the software is not determining good or bad a person is). In these cases validation is not required?