Electronics Forum | Mon Apr 15 11:44:09 EDT 2019 | cyber_wolf
Sorry that list is supposed to be bulleted. Site is acting weird
Electronics Forum | Tue Apr 09 17:33:45 EDT 2019 | tey422
I just assigned to make an IQ/PQ/OQ validation report to prepare for a couple of new yet very simple medical assemblies we are to build for. I have no idea how to make this report. All I know is I have to come with the validation report for all the
Electronics Forum | Fri Apr 12 14:47:50 EDT 2019 | slthomas
Do you have some IQ/OQ/PQ records for other validations that you can use as templates?
Electronics Forum | Wed Apr 10 17:15:26 EDT 2019 | davef
Here's a good summary: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM466496.pdf
Electronics Forum | Fri Apr 12 11:37:59 EDT 2019 | slthomas
Are you currently ISO 13485 certified, or are you just trying to meet compliance standards for a certified customer?
Electronics Forum | Mon Apr 15 12:10:00 EDT 2019 | slthomas
"To qualify the equipment for production use, you need to only do IQ, OQ." Even in a scenario where you're installing a piece of duplicate equipment, how do you demonstrate (and record) that the new machine provides acceptable product?
Electronics Forum | Fri Apr 12 18:00:23 EDT 2019 | tey422
That's the most difficult part I am trying to figure it out. I am unable to locate an IQ/OQ/PQ record that I could use as a template. That's why I am looking for if there is a sample one out there, which I can use it as the reference.
Electronics Forum | Fri Apr 12 14:17:40 EDT 2019 | tey422
We are ISO 13485 Certified. The previous PE who handles such technician things is no longer working with us. I am not sure where to start at, and what exactly needs to be done. Current, my main question is there some sort of a list what would be the
Electronics Forum | Mon Apr 15 12:45:49 EDT 2019 | slthomas
The reason I asked is that in every AS9100 or ISO13485 environment where I've been employed our equipment qualifications have included a PQ in order to provide evidence that the machine can (and did) produce product that meets or exceeds the pass/fai
Electronics Forum | Mon Apr 15 12:22:21 EDT 2019 | cyber_wolf
You demonstrate it and record it by the report. The report contains the check off items that you defined in the protocol along with supporting data from the testing you did. This usually involves part numbers,data points, and photos. The report shou
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