Structured Content Authoring for
CMC Analytical & Process Deliverables

Enhance Your Digital Transformation Strategy with Structured Content Authoring

Compass® BIO is a Structured Content Authoring application suite for CMC (Module 3) reports including both analytical and process reporting. A key function of Compass® BIO is the automatic generation of complex data tables imported directly from source data (analytical), process (recipe), and direct authoring as required.

Compass® BIO facilitates comprehensive Criticality Analysis reporting as well as Stability, Batch, and other reports with data-driven tabular organization of all structured data to facilitate rapid report generation from reusable project templates. Reports generated by Compass® BIO enable a single set of tables and reports for use by CMC development, lifecycle management, and regulatory teams. Compass® BIO supports initial reporting as well as dynamic growth for annual reporting updates.

From source to submission, Compass® BIO provides structure to all CMC data, connections, and filings.

Find Out How You Can Empower Your
Digital Transformation Strategy with True Structure

Available Applications

Compass® BIO is a suite of applications supporting pharmaceutical CMC (Module 3),
with additional applications in development.


Highly Structured,
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
Report Generation

Drug Stability, Batch Analysis, Justification of Specifications, Comparability, Recipe, Criticality Analysis, Detailed Process Flow Diagrams/Tech Transfer, Specification Document, and others.

Source Agnostic
Data Import

For analytical data sets including LIMS, ELN, CSV, Data Lakes, Recipes, and other sources.

Data Integrity

Users can never alter source data. Detect unclean data on import.

Chain of Custody /

Comprehensive workflow / review / approve / release with user roles.

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

What Our Customers are Saying
about Compass® BIO

Cognition Corporation’s Compass® BIO is our electronic reporting environment supporting automated transcription and aggregation of large analytical data sets from data sources to tabular reports to submissions.”
– Senior Scientific Director, Strategic Science and Innovation
There is inherent risk in manual transcription of 20,000 data points, even with strong procedural controls for manual data verification. With Cognition, all data is pulled from LIMS and the data tables generate automatically. We have reduced the number of data touches and significantly improved our report data integrity.”
– Director, Data Analytics
We have eliminated the tedious process of data table verification for our stability reports. We have also reduced the time to create large stability reports from 40 days to less than 20 days. The Compass® BIO stability reporting application is saving us the equivalent of 3 full-time resources every year.”
– Senior Scientist, Informatics
We have tamed the beast of Criticality Analysis with Compass® BIO. It lets us import or create recipes or process definitions, identify CQA, and create complex risk analysis for all products. Our LM API teams consider it a core application.”
– Senior Scientific Director, Strategic Science and Innovation

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See How Compass® BIO Can Help You Get to Market Faster, With Complete Traceability.