Structured Content and Data Management System for Drug Development CMC Module 3 Common Technical Documents Automated Report Generation

Enable Your Drug Development CMC Digital Transformation Strategy with a Structured Content and Data Management (SCDM) Guided Workflow System

The Chemistry, Manufacturing, and Controls (CMC) Module 3 component of the Common Technical Document (CTD) required for pharmaceutical regulatory submissions requires extensive documentation, including drug substance and drug product information, manufacturing processes, analytical methods, stability studies, and more. Managing the manual transcription and compilation of this documentation consisting of text annotations, images, data, tables, etc. from various sources while ensuring accuracy, consistency, clarity, and coherence across different sections of the report can be very challenging and can often times result in data integrity errors and risks. 

Cognition Corporation’s Compass BIO software suite of applications for CMC module 3 reports —specifically created for pharma, biotech, and CDMO companies—is an innovative, technically driven digital CMC software solution to help biopharmaceutical companies navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking.  Compass BIO supports both large molecule (biologics) and traditional small molecule products.

An Out-of-the-Box CMC Module 3 e-Reporting Solution

Compass BIO has been strategically developed as a Structured Content and Data Management (SCDM) system with a suite of configurable applications software for CMC Module 3 reports that automates data pipelines and includes both analytical and process reporting. An innovative and unique key functionality of Compass® BIO is the automatic generation of complex data tables imported directly from source data without manual data transcription (analytical), process (recipe), and direct authoring required.

The out-of-the-box, configurable suite of software applications provide a virtual guided workflow system that manages and enables a data pipeline for creating, assembling, ordering, navigating, approving, and repurposing content for data usage more consistently and efficiently throughout the drug development lifecycle, while also identifying any data quality issues found and providing an audit trail for any data quality decisions taken.

Compass BIO reduces the resources needed to create, review, approve, release, and update reports. The deliverables generated by the Compass BIO Structured Content and Data Management system enable a single set of data tables and reports for use by CMC development, lifecycle management, and regulatory teams. The software can also identify data quality issues and flag them for expert review to improve data integrity, and it works with both analytical data (LIMS, data lakes, etc.) and process data (recipes, process development, etc.)

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

Applications Available

Compass BIO is a suite of software applications, for generating Drug Development e-Reports for biologics and small molecules, that have been developed to be used individually or combined. Compass BIO can facilitate the generation of both structured analytical and process data reports with data-driven tabular organization of all structured data to facilitate rapid report generation from reusable project templates that can be used throughout product development.

Reports generated by Compass® BIO enable a single set of tables and reports for use by CMC development, lifecycle management, and regulatory teams.

The analytical data software suite of applications can include Specification Documents, Batch Analysis Reporting, Drug Stability Reporting, Comparability Reporting, and Justification of Specification Reporting capabilities.  The process data software suite of applications capabilities can include Criticality Analysis, Process/Recipe, and Detailed Process Flow Diagrams.  For example, the Criticality Analysis reporting and Drug Stability reporting applications may be used in combination as a starting point for adopting a Structured Content Data Management solution and over time additional software applications can be added to further enhance the ability to fully automated CMC Report Generation.

There is a Better Way to Manage Your CMC Module 3 Data

By implementing a Structured Content Data and Management (SCDM) approach, and workflows with built-in configurable templates, tables, and data reports, the user experience is significantly streamlined, simplified, and improved. The built-in capabilities of Compass BIO also allow users to follow guided processes and workflows in real-time that include company-embedded processes and work instructions that comply with company SOPs and policies.

Compass BIO also ensures the integrity and consistency of data throughout the drug development lifecycle by organizing data in standardized configurable formats which minimizes data error risks, permits efficiency in data exchange, and reduces the time required to complete e-Reporting (such as eCTD CMC module 3 documents) for filing with various regulatory health agencies. 

From source to submission, Compass BIO reduces the resources needed to create, verify, release, and update CMC Module 3 reports. Additionally, the output generated by the Compass BIO Structured Content and Data Management system enables standard established data tables and reports for use by CMC development, lifecycle management, and regulatory teams.

Key Benefits

Improve data integrity, accuracy, and efficiency with the innovative Compass BIO Structured Content and Data Management System

Improve Data Integrity

Minimize errors, redundancies, and discrepancies, enhancing the reliability and accuracy of information. Users can never alter source data. Detect data quality issues on import. Internally structured data items are access controlled, reusable, and include comprehensive audit logs.

Automate Submission-Ready Reports

Generate highly structured, reusable data items & comprehensive reports of large CMC data sets with automatic generation of complex data tables and reports and the ability to use dynamic links between data items, and collections/containers of data items.

Data “Single Source of Truth”

A single set of data tables and reports is used through the entire process, therefore 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.


Ensure consistency and standardization in formatting, terminology, and content across CMC documents. This consistency enhances clarity and reduces ambiguity, making it easier for regulatory agencies to review and assess the information provided.

Enhanced Regulatory Compliance

Help ensure compliance with regulatory requirements by maintaining comprehensive documentation and audit trails to support regulatory submissions, inspections, and compliance with guidelines such as GXP.

Efficiency & Cost Savings

Streamline the collection, organization, and retrieval of CMC data by automating manual efforts & repetitive tasks and providing templates and predefined fields, resulting in accelerating the writing process and document preparation.

What Makes Compass BIO Unique?

  • Utilize guided workflows and built-in templates to ensure consistency and compliance
  • Automate the process & analytical report generation of complex data tables and report generation for Criticality Analysis, Drug Stability, and other CMC Module 3 sections required for the Common Technical Document (CTD).
  • Maximize flexibility with source agnostic data import and multiple export format choices:  Import from LIMS, ELN, CSV, Data Lakes, Recipes, and other sources. Export to FHIR, XML, JSON, PDF, etc.
  • Ensure quality and traceability because users cannot alter source data and all actions are controlled through configurable templates with document review and release.
  • Document a Verifiable Chain of Custody / Evidence by using comprehensive workflow / review / approve / release with user roles.
  • Purpose-built by a team of developers, engineers, and industry-focused experts who have been providing product development and technical SaaS solutions for more than 20 years to the life science industry.

What Our Customers Are Saying About Compass BIO

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