First Scenario: All votes equal to "Ready for Approval"
Step-by-Step Guide PRC Review Parallel workflow: First Scenario: all votes equal to "Ready for Approval"Second Scenario: At least one vote equal to "Approved with Changes" and none equal to "Not Approved" or "Revise and Resubmit"- Minor Changes are required
Step-by-Step Guide PCR Review Parallel workflow: Second Scenario: At least one vote equal to "Approved with Changes" - Minor Changes are requiredThird Scenario: At least one vote equal to "Revise and Resubmit" - Major Changes are required or at least one vote equal "Not Approved"
In case after the PCR review meeting the vote "Not approved" persist, MLR Coordinator can cancel the piece. In case reviewer change their decision, other PCR Review will take place
Step-by-Step Guide PCR Review Parallel workflow - Third Scenario: At least one vote equal to "Revise and Resubmit" - Major Changes are requiredFirst Scenario: All votes equal to "Approved for Distribution"
Submission is not required
Step-by-Step Guide PCR Approval workflow: First Scenario: All votes equal to "Approved for Production" and Submission is not required.Submission is required
Second Scenario: At least one vote equal to "Not Approved"
PCR Re-Approval - First Scenario: Approved for Continues Use
Step-by-Step Guide PCR Re-Approval: First Scenario - Approved for Continues UsePCR re-Approval - Second Scenario: Not Approved for Continued Use
Veeva Vault
PRC Proccess.vsdx
vault_users_Neurotech_JM_v2.xlsx (sharepoint.com)
https://forms.office.com/r/zshb1njgyV