Regulatory Open Forum

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  • 1.  Electronic Batch Records

    Posted 15-Jun-2021 14:09
    My current company is looking at implementing an Electronic Batch Record. Does anyone have any recommendations on providers? We would like it to be cloud based, able to be implemented across multiple sites and be able to implement new batch records with ease (hopefully without needing the expertise of the provider).

    Thanks

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    Keri Froese RAC
    Ottawa
    Canada
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  • 2.  RE: Electronic Batch Records

    Posted 18-Jun-2021 11:16
    ​We are currently working on transitioning our batch records to DocuSign. Unfortunately, it's not the most intuitive for our process but it will provide improvement/efficiency from our current paper process. In general, it's pretty easy to create templates, set signing orders, and send to users for data entry/signature.

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    Stacey Benser
    Senior Quality/Regulatory Manager
    York PA
    United States
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    Original Message


  • 3.  RE: Electronic Batch Records

    Posted 23-Jun-2021 12:34
    Edited by Loganathan Kumarasamy, MS RAC 23-Jun-2021 12:34
    We have seen variety of systems being used and predominantly SAP based ones like SiBR and also Oracle Manufacturing Records. We have done Batch record evaluation for few customers and it typically varies based on the need and usage volume.

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    Loganathan Kumarasamy, MS RAC
    Associate Director,
    Toronto, Canada
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    Original Message


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