Module 12 2019

Example Document Workflow

2.7.3 SCE ‐ Final Clinical Study Report 2.7.3 SCE TLG Alignment Meeting + Outline 2.7.3 SCE Update Shell with last batch of Dry Run TLGs 2.7.3 SCE Review 1 2.7.3 SCE MW Updates 2.7.3 SCE Review 2 2.7.3 SCE MW Updates 2.7.3 SCE Team Endorsement 2.7.3 SCE Final TLGS to MW (ISE TLGS Delivered) 2.7.3 SCE MW Updates 2.7.3 SCE Review 1 post final TLGs 2.7.3 SCE MW Updates 2.7.3 SCE Review 2 post final TLGs 2.7.3 SCE MW Updates 2.7.3 SCE Document Quality Review 2.7.3 SCE MW Updates 2.7.3 SCE Leadership approval 2.7.3 SCE Final - Available in Document Management System 2.7.3 SCE Final – Publishing Preparation / Initial QC

2.7.3 SCE Final – Publishing External Link QC / Submission Ready

MILESTONE: 2.7.3 SCE Final Submission Sciences Submission Ready

The Organisation for Professionals in Regulatory Affairs