Software Validation - FDA Regulations and Requirements

Does anyone know if there are any specific FDA regulations (other than 820.70(i) and 820.72(a)) for validation of non-product software used as part of the production process?

Actually, just getting a clear definition of the term “non-product software” seems to be difficult. For my company, it’s the custom software we use to validate subassemblies and finished devices. The collected data is used for SPC quality trending.

It does not include any off-the-shelf software such as MiniTab or MRP/ERP systems.

Re: Software Validation - FDA Regs

Quality96 said:

Does anyone know if there are any specific FDA regulations (other than 820.70(i) and 820.72(a)) for validation of non-product software used as part of the production process?

Actually, just getting a clear definition of the term “non-product software” seems to be difficult. For my company, it’s the custom software we use to validate subassemblies and finished devices. The collected data is used for SPC quality trending.

It does not include any off-the-shelf software such as MiniTab or MRP/ERP systems.

Click to expand...

I havent come across the term "non product software". Are you refering to the "Off-the-Shelf" software ?

To answer your question on software validation, take a look at the General Principles of Software Validation; Final Guidance for Industry and FDA Staff. The Appendix A would give lot of references to the FDA documents.

I work for a medical device company that is currently looking to switch from SAS to another (cheaper, maybe quicker) statistical software program. I was wondering if there was a reason for insisting that SAS be the preferred program.

Also, if Minitab could be compliant with the FDA's standards, has anyone gone through the validation process before?

Thank you!

Quality96 said:

Actually, just getting a clear definition of the term “non-product software” seems to be difficult. For my company, it’s the custom software we use to validate subassemblies and finished devices. The collected data is used for SPC quality trending.

Click to expand...

Building on Ajit's post -- check out section 2.4 of the document he cites: "any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging distribution, complaint handling, or to automate any other aspect of the quality system.

I am traveling down the non-device software validation road myself, in my travels I have come across this book:

"Medical Decide Software Verification, Validation, and Compliance" by David Vogel.

(I can't post links yet, sorry.)
[FONT=&quot]
The part of the book that is especially pertinent to your question is Chapter 15 -- you can peruse it using Amazon's Look Inside feature.

I found this book to be very helpful -- once I read it, I found that FDA guidance stuff suddenly made a lot more sense. (Opinions may vary of course)

HTH - Arianna
[/FONT]

Thanks for the reference to this text; the previews are very informative. As the Q.E. generally tasked with the software validation of tools up to and including certain Excel, Access & Adobe Acrobat applications in my Company, I'm encouraged when our ISO 13485 surveillance auditor concurs with my QM to "keep it simple", but have always wanted more rationiale for avioiding overkill while meeting all requirements. My favorite quote from early in the text: "If you feel like you're wasting time, you probably are."...