FDA Requirements - Printing Equipment Software Validation

Hello. We are a contract manufacturer & make 1 'finished' medical device (not labeled, packaged, or sterilized but functional). Our company builds our own capital printing equipment & provide the service of printing. We are being asked to do a SW Validation for this equipment. It talks to our network, obtains specified AutoCAD files (generated by Engineering years ago during the process validation with the OEM) then those direct the printer what & where to print; there is 1 machine per printing step. We 100% electrically test all parts & 100% visually inspect. We have had 0 field failures in all the years we have done this. The handful of customer complaints are unrelated to this. We have validated our automated Excel spreadsheets & test software that we developed, however this has not come up before. How can we best & most easily meet the requirement? Thank you!


Staff member
Apologies for the delay. This is for 3D printing, right?

How can we best & most easily meet the requirement?
The short answer is to validate it! :) Seriously, it is software used in the production process so it needs to be validated. Validating is more than testing - it's about demonstrating control as well. I personally like the IQ/OQ model. In your case, most of the operational aspects can be effectively waived due to your post-processing inspections / tests. However, if there is error checking / detection (i.e., you submit a CAD file that can't be printed), you can demonstrate that as part of OQ. (If you want to avoid future arguments, you may want to do some OQ tests for boundary type pieces - largest, smallest, most complex geometries). You'll want to show (i.e., in IQ) that the software is running on a system that properly supports it (memory, processor speed, etc.), the binaries are properly protected (i.e., you can't just willy-nilly load new software), and that changes are made in a controlled manner.

You *should* consider a Master Validation Plan that establishes a risk-based approach to your software validation activities and then create an inventory of software with a risk assessment for each and the validation requirements for each.