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FDA 21 CFR part 11 compliance

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DashiellNico
Crewman
Crewman
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FDA 21 CFR part 11 compliance

Hi,

I am researching the implication of FDA 21 CFR part 11 compliance for a new SCADA system. I've done a bit of browsing on the internet and it appears to boil down to procedures for engineering and requirements for the storage of data and signatures.

Does anyone have recommendations for further reading, like books or articles related to FDA 21 CFR part 11 compliance for SCADA systems. I'm planning to hire expertise but I'd like to know what I'm getting into in advance.

1 Reply 1
MartinChartrand
Captain Captain
Captain
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Re: FDA 21 CFR part 11 compliance

Hello @DashiellNico,

As this appears to be a pharmaceutical specification, we would need to know a bit more about the application and what specifics you would like addressed. Many parts of the standard refer to implementation and not products.

 

You can contact me directly at martin.chartrand@se.com if you'd like.

 

Regards,

Martin Chartrand