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Help CMOs correctly follow a path for proper notification to OTI when changes are made to our processes                     NON-CONFORMANCE/DEVIATION has Occurred         Zyfine Quality forwards begins drafting the deviation or Non-Conformance Event.         Zyfine Notifies Onconova Quality Assurance By Email within 2 business days         Onconova Acknowledges Receipt.         Zyfine Completes investigation within 30 business days, Submits investigation report to Onconova for Review and Approval       Onconova doesn't agree with Investigation, Notifies Zyfine via email NO Onconova Reviews Investigation, and decides Approval YES Onconova Approves Investigation, notifies Zyfine.     Zyfine addresses comments and Concerns. Resubmits report to Onconova for Review and Approval.   Zyfine Completes and Archives investigation Report. Provides final copy with Batch Record Package.