Rebecca Halbur

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  • in reply to: IP Related Docs #2786
    Rebecca Halbur
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    Hi Brad,
    We recently had an MHRA inspection with Andy Fisher as our lead inspector. We have approximately nine systems in which various documentation is housed that would be considered inspectable but not filed in our core eTMF system. We prepared access for all of these systems (in line with E6), but Andy and his team ended up only wanted direct access to our core system and guided access to the others.
    We are still maintaining the option for direct access in the future as another inspector may have a different preference, but in my most recent experience, I can say that we ended up doing guided access for these disparate systems as needed.

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