Business Continuity Requirements
Reply to Thread
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
Did I see something in the latest MHRA guidance on GXP data integrity?
MHRA July 2016 draft guidance -- "Business continuity arrangements should be included in the contract, and tested".
I'm sure that the MHRA GCP Guide (2012) has something in it. Also EMA & FDA Data Integrity guidance might be useful.
the MHRA July 2016 draft guidance on GXP data Integrity -- "Business continuity arrangements should be included in the contract, and tested": the MHRA GCP Guide (2012): EMA & FDA Data Integrity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.