COMPASS® BIO
Structured Content and Data Management for
Common Technical Documents – CMC Module 3
Find Out How You Can Empower Your
Digital Transformation Strategy with True Structure
“It’s not about the pretty pictures, but the heavy lifting of the data tables.”
Features
Driving efficiency and accuracy with Structured Content and Data Management.
Highly Structured,
Reusable Data Items & Reports
Dynamic links between data items, and collections/containers of data items to rapidly generate comprehensive reports of large CMC data sets.
Process & Analytical
Report Generation
Automatic generation of complex data tables and reports per company SOP and ICH regional standards.
Source Agnostic
Data Import & Flexible Export
Import from LIMS, ELN, CSV, Data Lakes, Recipes, and other sources. Export to FHIR, XML, JSON, PDF, etc.
Data Integrity
Users can never alter source data. Detect unclean data on import. Internally structured data items are access controlled, reusable, and include comprehensive audit logs.
Chain of Custody /
Evidence
Comprehensive workflow / review / approve / release with user roles. Supports customer defined Virtual Process Workflow.
Single Report /
Data Table
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.”
Cognition Actively Promotes Data Transformation Strategies to Support Digitalization of Submissions
Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. This article describes advancements made within the pharmaceutical industry from theoretical concepts to utilization of structured content and data in CMC submissions.
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