Implementation Timeline for EDMS & Submission Publishing
Implementation Steps | 1Q | 2Q | 3Q | 4Q | 5Q | 6Q |
| Gather requirements; determine validation requirements | ||||||
| Identify potential vendors; select short list | ||||||
| Prepare & issue RFP, reduce vendor list, start negotiations | ||||||
| Order & install hardware; install vendor software, perform IQ/OQ validation | ||||||
| Train users, help desk, administrators; perform UAT & PQ validation | ||||||
| Produce small submissions – INDs, Annual Reports, Amendments, Supplements, Safety Updates | ||||||
| Produce marketing application & submit |