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21 CFR Part 11 Implementation

StolzEnter

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.

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  • 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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  • 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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