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SteveK
Right, I’ve put together a procedure – so I meet the first requirement of this new clause in ISO 13485:2016. I am familiar with IQ, OQ and PQ having conducted various process validations. There are the software validation guidelines from the FDA and there is AAMI/TIR 36, but these seem far too complex for off-the-self stuff. It is how far do you go down the rabbit hole? For example we have new labelling software which produces text and barcodes for our products/packaging, so this obviously has an impact on our QMS. We have barcode verifiers (1D and 2D) which I can use as part of the print validation exercise. However, these verifiers also run on software which in turn has therefore an impact on the QMS – so how do I validate this software I use in part to validate?
Also, CAD software is part of our QMS since it produces the drawings which we manufacture to. How do you validate this? Then there is our accounting software which produces a bill of materials which we manufacture to – further impact on our QMS – how to validate this? It can then get a bit silly when you then consider operating systems, Adobe, Word, Excel (though in Excel I do understand the issues with macros and formulas and the examples in TIR 36).
I do have a number of ideas how to conduct such software validation based on input and output, risk, fitness for purpose, specification meeting OQ, screen capture, test printouts etc., but would appreciate anybody else’s experience and thoughts.
Steve
Also, CAD software is part of our QMS since it produces the drawings which we manufacture to. How do you validate this? Then there is our accounting software which produces a bill of materials which we manufacture to – further impact on our QMS – how to validate this? It can then get a bit silly when you then consider operating systems, Adobe, Word, Excel (though in Excel I do understand the issues with macros and formulas and the examples in TIR 36).
I do have a number of ideas how to conduct such software validation based on input and output, risk, fitness for purpose, specification meeting OQ, screen capture, test printouts etc., but would appreciate anybody else’s experience and thoughts.
Steve