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Business Continuity Requirements

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  • Anon
    17/08/2016 07:42
    Looking for a reference document pertaining to the requirements for business continuity planning and testing in a GCP context. I have looked at DIA but their guidance issued in 2008 is no longer available. Is there a replacement? Thanks
  • Anon
    18/08/2016 08:57
    Did I see something in the latest MHRA guidance on GXP data integrity?
  • Anon
    18/08/2016 09:00
    MHRA July 2016 draft guidance -- "Business continuity arrangements should be included in the contract, and tested".
  • Anon
    18/08/2016 09:02
    I'm sure that the MHRA GCP Guide (2012) has something in it. Also EMA & FDA Data Integrity guidance might be useful.
  • GCP Com
    18/08/2016 19:54
    the MHRA July 2016 draft guidance on GXP data Integrity -- "Business continuity arrangements should be included in the contract, and tested": the MHRA GCP Guide (2012): EMA & FDA Data Integrity guidance; the PIC/S Annex 11, section 16, has a useful summary; EMA GVP Module I b11 if PV related. >> Others might have other references. The DIGIT Computing Committee might have some good references.
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