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.
|
| |
| |
|
|
|
|
|
|
|
|
|
|
Quality System Flow Chart
More flowcharts
