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Internal SOPs aside, when MUST a configuration change to an electronic QMS be captured in a Change Control? Question Id:6901
Deven roberts
08-05-2019 06:08AM
User Id: 186782
With Reference to Webinar - Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR (ID - 701687)
I understand that if I were to make a change that would put our electronic QMS out of a state verified/allowable/approved during the validation process into an UN-validated state, this would need to be captured in a Change Control. However, is there any regulatory standard/requirement that requires ALL changes of a certain type/types to be captured via change control? Or is acceptable to define and justify the risk for each change as QA?
Points for this question:10

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