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FDA and FileMaker

john renfrew

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I have a UK client with some US customers, and they would like the next version of their system, which manages printing, labelling and quality control at the edges of the medical field, to get their quality control and printing system validated - for FDA approval.


Does anyone have experience of doing this with FileMaker as the core component, who might be prepared to share pitfalls especially??

Not necessarily expecting all advice to be free...

Links to other helpful discussions welcomed.



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Hi John I am working with a client in the medical field that sells worldwide we are doing manufacturer labeling, they have to deal with CE and ISO and FDA for the quality control of the products. 

I am not sure what "validated" means other then that your system generates the output with the required symbols and icons or meets the guidelines.

I don't know too much of the specifics as I am just digging in to the core solution myself and redeveloping printing their labels from FMP vs a word template. 

If there are specific FDA questions you have I can ask them they may be able to provide something useful?

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There's the document >>General Principles of Software Validation on the FDA site, and various others which hang off it. 

This is a total rewrite of their system as one of the principles is 'tell us what the system will be doing' and then 'show us that is does what you said it would' and how you handle errors in the development cycle.



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Sounds very similar to the ISO standards that this client is preparing for - they had hired an ISO consultant to preflight all their books kind of an internal self audit, before they have the real one. I wasn't fully in on all the discussion but from what I got out of things was that the physical process must match the things that are required by any agency or law or industry standard. And that the documentation for the process matches. ( including all the forms ) what you title things should match the sample forms / labels in the binders and a common vocabulary - and when a form is changed the that the documentation reflects the change - i think that is how things get out of sync - what the document says is not how things work in real life - people invent shortcuts or optimize processes but fail to update the procedure documentation.

For example the document said something about products that fail QC - in real life they just throw them in the Sharps container or biohazard bin - so that that lot isn't used or put into inventory. The document didn't specify in precise enough details the process, so it was flagged as something that needs updating.

As far as the computer part of the process - the consultant really didn't provide much details or directions - I think this round he was mostly reviewing the paper documents.

I remember back in the 90's I knew someone manufacturing parts via injection molding equipment for the medical industry and at that time he had a Mac SE30 sitting there with a home made data acquisition system logging every time the machine spit out a part - that logged the date, time, lot, instrument settings etc. I remember this, as he was so proud because, it was blessed by the FDA. 


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