COMPASS® BIO
A suite of applications designed for CMC development, enabling Quality by Design (QbD) for both large and small molecule products
Enable Your CMC Digital Transformation Strategy with a Structured Content and Data Management (SCDM) System
Accelerate your CMC (Chemistry, Manufacturing, and Controls) digital transformation with Compass BIO, a robust Structured Content and Data Management (SCDM) system. Developed by pharmaceutical industry experts, Compass BIO streamlines the CMC Module 3 process of the Common Technical Document (CTD), managing everything from drug substance and product data to manufacturing processes, analytical reporting, and stability studies.
CMC processes generate massive amounts of data from sponsors, CDMOs, and suppliers, often stored in unstructured formats across disparate systems. These inefficiencies result in data lacking the necessary context for lifecycle management and regulatory compliance.
Say Goodbye to Manual Transcription and Data Inefficiencies
Compass BIO eliminates the need for manual data transcription and aggregation. With guided workflows, structured templates, and automated data pipelines, Compass BIO enhances accuracy, consistency, and coherence across your reports—minimizing data integrity risks and saving time.
An Out-of-the-Box CMC e-Reporting Solution
Compass BIO has been strategically developed as a Structured Content and Data Management (SCDM) system with a suite of configurable software applications for CMC Module 3 reports, automating data pipelines and supporting both analytical and process reporting. A key innovative feature of Compass® BIO is its ability to automatically generate complex data tables directly from source data, eliminating the need for manual data transcription, process input, or manual authoring.
The out-of-the-box, configurable software suite provides guided workflows that streamlines the data pipeline for creating, organizing, and approving data and content throughout the drug development lifecycle. It also identifies data quality issues and provides an audit trail for all data quality decisions made.
Key Features of Compass BIO
- Compatibility with both analytical (LIMS, data lakes) and process data (recipes, development)
- Automatic generation of complex data tables directly from source data
- Configurable templates for seamless report creation
- Audit trail to document data quality decisions
From source to submission, Compass BIO brings structure to CMC process data, ensuring compliance, accuracy, and efficiency at every stage.
Applications Tailored to Your Needs
Compass BIO is purpose-built to generate e-Reports for both biologics and small molecules. Whether used individually or combined, our suite of applications simplifies report generation by organizing structured analytical and process data into dynamic, reusable templates.
Key Applications include:
- Analytical Data Suite: Specification, Batch Analysis Reporting, Drug Stability Reporting, Comparability Reporting, and Justification of Specification Reporting.
- Process Data Suite: Criticality Analysis, Process/Recipe Reports, and Tech Transfer.
Start with Criticality Analysis or Drug Stability reporting, then scale your solution over time to fully automate CMC report generation for your organization.
Take Control of Your CMC Data
With Compass BIO’s Structured Content Data and Management (SCDM) approach, you can streamline your reporting process. The platform’s real-time guided workflows, built-in templates, and configurable tables improve user experience while maintaining company SOPs and compliance policies.
Compass BIO ensures data integrity throughout the drug development lifecycle by organizing data into standardized formats, reducing errors, and speeding up regulatory e-Reporting, including eCTD CMC Module 3 submissions.
From source to submission, Compass BIO reduces the time, effort, and resources needed to create, verify, release, and update your CMC reports.
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 sees and uses exactly the same tables and reports as the CMC team and all users on the path from source to submission.
Standardization
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 25 years to the life science industry.
What Our Customers Are Saying About Compass BIO
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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