Regulatory Open Forum

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  • 1.  Digital Signature Hardware/Software

    Posted 13-Apr-2012 18:26
    Can anyone recommend a source for FDA Part 11 compliant electonic signature hardware/software programs in Canada?  Thank you.

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    Merle Kirkpatrick
    Manager, Regulatory and Quality
    Oncolytics Biotech Inc
    Calgary AB
    Canada
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  • 2.  RE:Digital Signature Hardware/Software

    Posted 26-Apr-2012 10:50
    You ask a very broad question,.
    It depends on the scope and application of the automation you are looking to utilize.

    There are numerous Product Data Lifecycle, Risk Management, Quality Management System, Document Management, Preventive Maintenance, and ERP automation applications that are part 11 compliant.

    I believe before anyone could make any recommendations we would need to know what scope or functionality are you looking for in automation? 


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    Michael Chellson
    RAC
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