Structured Content Authoring for
CMC Analytical & Process Deliverables
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Digital Transformation Strategy with True Structure
Reusable Data Items
Dynamic links between data items, and collections/containers of data items to rapidly generate comprehensive reports of large CMC data sets.
Process & Analytical
Drug Stability, Batch Analysis, Justification of Specifications, Comparability, Recipe, Criticality Analysis, Detailed Process Flow Diagrams/Tech Transfer, Specification Document, and others.
For analytical data sets including LIMS, ELN, CSV, Data Lakes, Recipes, and other sources.
Users can never alter source data. Detect unclean data on import.
Chain of Custody /
Comprehensive workflow / review / approve / release with user roles.
Single Report /
A single report / data table is used through the entire process: “the Dossier group see and use exactly the same tables and reports as the CMC team and all users on the path from source to submission.”
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