Regulatory Open Forum

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  • 1.  GSPR Checklist Ownership

    Posted 19-Jan-2022 13:05

    Good morning everyone!

    Can you share how the GSPR checklist ownership is handled in your organization? Is the document owned by the device team, regulatory team, quality or another group? Understanding that it's a team effort to complete the checklist but just curious as to which group "owns" the document. 

    Thanks!

    Sabrina 



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    Sabrina Dessources
    Boston MA
    United States
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  • 2.  RE: GSPR Checklist Ownership

    Posted 19-Jan-2022 13:35
    I prefer that the GSPR checklist be owned by the regulatory group.  Though the checklist cross-references various documents that may themselves be owned by other functional areas, the checklist is intrinsically a regulatory document generated for regulatory/legislative purposes.  A proper GSPR checklist has too many regulatory nuances to leave it to the ownership of areas other than the regulatory group.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: GSPR Checklist Ownership

    Posted 20-Jan-2022 09:32
    Thanks Kevin!

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    Sabrina Dessources
    Boston MA
    United States
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    Original Message


  • 4.  RE: GSPR Checklist Ownership

    Posted 20-Jan-2022 04:55
    Hi Sabrina,

    at our site this is under the ownership of Quality, as we have a dedicated department dealing with technical documentation oversight. The deliverable to validate all GSPRs however are certainly located throughout the whole company.

    Hope that helps - All the Best

    Markus

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    Markus Lantermann
    Head of Q&R Region International
    Mannheim
    Germany
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    Original Message


  • 5.  RE: GSPR Checklist Ownership

    Posted 20-Jan-2022 09:33
    Thanks Markus!

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    Sabrina Dessources
    Boston MA
    United States
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    Original Message


  • 6.  RE: GSPR Checklist Ownership

    Posted 20-Jan-2022 10:33
    Hello,

    I'll chime in to echo what Kevin said. In past lives, this was a regulatory document, though with the advent of MDR/IVDR, it required a lot of input and feedback from other groups (QA, product development, R&D, clinical affairs, etc.)

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    Corey Jaseph RAC
    Senior Research Analyst
    Wheatland CA
    United States
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    Original Message


  • 7.  RE: GSPR Checklist Ownership

    Posted 25-Jan-2022 08:06
    Thanks!!

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    Sabrina Dessources
    Boston MA
    United States
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    Original Message


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