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Harmony - Coggle Diagram
Harmony
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Manual Process today
RA teams stitch data from QA, R&D, manufacturing, plants
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Data Landscape
99% unstructured — scanned PDFs, photos, emails
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Platform Features
4 User Rolees
RA Head: configure departments, roles, users, permissions
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QA: upload source documents (test data, studies)
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Dossier templates
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FDA template, India template, EMA template
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Sequences (Versions)
Every change requires a new sequence (e.g. 000, 001, 002…)
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What Harmony Solves?
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Multi Country
Approved in FDA → reuse for Japan, India, Africa, EU
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Scope & Coverage
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Moving part 3 — Modality
Currently: solid orals (tablets, capsules) — generics
Future: parenterals (injections), syrups, biologics
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