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Question post in webinar from Somalia
So you are saying that if digital products don't resemble paper products auditors have a hard time checking if they are compliant? Can you add a bit more details as this is an interesting comment
QMS models clash with modern digital AIM products unless they mimic their paper predecessor in terms of expected contents and the ability to determine the repository is up to date. While this issue is not currently a huge concern at the state and country level, a growing solution need is rapidly becoming evident for entities requiring global data perspectives. Home baked versions like I pioneered in 2009 work for now but rightfully raise the brow of any audit opportunity unless your company has the ability to hold the auditor's favorite carrot in front of them.