21 CFR Part 11 Implementation

StolzEnter over 5 years ago

Hello All,

Hope You are doing Well..

I need some help regarding following things in Citect SCADA.

1.How to Implement Logging in Citect SCADA for Tags and Alarms

2.Long term storage of these tags and alarms ( for 3 yrs)

Also how can I view the old data and alarms for trends and alarms resp.

3.Implementing Audit trials and other aspects of 21 CFR Part 11 like User Management, Reports etc.

Please help

Thanks.

StolzEnter over 5 years ago

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Bradley over 5 years ago

Hi StolzEnter,

A paper with example project was written for this in about 2008. It is titled "Implementing Vijeo Citect to meet the requirements of FDA 21 CFR Part 11".
To my knowledge it has not been updated with any product advancements (or branding). I would recommend contacting Customer Support to see if they have it available for you.

I couldn't find it myself on the Support site.

regards,

bradley
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StolzEnter over 5 years ago

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Regarding 21 CFR clauses implementation to CITECT 2018
Thanks.
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Olivier over 5 years ago

Hi StolzEnter,
You can download the guide here:
https://www.se.com/hk/en/download/document/Vijeo%20Citect%20FDA%2021%20CFR%20whitepaper/
As Bradley mentioned, it has not been updated in a while.
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Stuart over 5 years ago

I would suggest that there a lot better ways of doing things, eg logging, in newer versions than those recommended in that document, by leveraging the new alarm back end/ SOE table etc. You would need to put some engineering into exporting it for the various purposes, but it should be more secure / redundant etc than logging to a file.
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