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Implementation Timeline for EDMS & Submission Publishing |
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| 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 | | | | | | |
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