Compass BIO

Compass® BIO is a Structured Content and Data Management SaaS solution designed for biopharma and CDMO organizations. It addresses the challenges of converting raw Chemistry, Manufacturing, and Controls (CMC) scientific data into technical reports and regulatory documents by providing traceable, standardized workflows that support regulatory compliance across the full product development lifecycle.

The platform is built around a Quality by Design (QbD) approach, enabling teams to manage complex data relationships for both large and small molecule products. It serves a broad range of stakeholders including CMC leadership, regulatory and quality leaders, technical writers, scientists, executives, and IT and digital transformation teams.

Core Capabilities

• Eliminates bottlenecks in the data pipeline with guided workflows that shorten the path from Target Product Profile (TPP) through Technology Transfer
• Standardizes data from sponsors, CDMOs, and suppliers into a single unified system to support lifecycle management and regulatory compliance
• Supports navigation, organization, aggregation, and generation of data tables, narratives, and formal reports
• Detects data quality issues and provides real-time traceability to reduce risk in regulatory submissions
• Automatically generates structured, reusable data items and reports for Module 3 of the Common Technical Document (CTD)
• Dynamically links data items to ensure completeness at the time of dossier submission
• Maintains a unified repository presenting a single set of data tables and reports throughout the entire development process
• Enforces uniformity in formatting, terminology, and content across all CMC documents through real-time guided workflows aligned with company SOPs and policies
• Maintains comprehensive documentation and audit trails to support regulatory submissions, inspections, and compliance with GXP guidelines
• Automates repetitive tasks and accelerates document preparation using pre-built templates and predefined fields

Platform Modules

• Repository: The core foundation of Compass BIO, defining data items and relationships to support working projects with rigorous control of reusable, trusted data. Included as built-in core functionality.
• Risk Module: A flexible data model supporting all types of risk data and relationships across pharma use cases. Included as built-in core functionality.
• Publisher Module: Supports automatic generation of external documents based on work completed within Compass BIO. Available as an optional add-on.
• Connector Module: Supports API and other connections for automatic two-way data transfer, reducing manual import and export. Available as an optional add-on.

Process Data Suite

• Manages data creation and risk mitigation through a structured data model, workflow actions, access controls, and comprehensive audit logs
• Reduces time required to generate reports for internal use and formal submissions
• Covers: Recipe/Process, Criticality Analysis, Technology Transfer, Critical Assets Risk Assessment (CARA)/eFMEA, and Hazard Analysis and Critical Control Points (HACCP)

Analytical Data Suite

• Ensures data integrity using approved, reusable data from the Compass BIO Repository
• Streamlines report generation, management, and publication, including automatic generation of formal reports for external formats and systems
• Provides chain of evidence through workflow controls, access management, and detailed audit logs
• Covers: Target Product Profile (TPP), Quality Target Product Profile (QTPP), Specifications (SPEC), Drug Stability, Batch Analysis, and Justifications of Specifications (JoS)

Deployment and Background

• Delivered as a SaaS solution with quick implementation and customization options to fit existing team workflows
• Modular applications can be used individually or as a combined suite to fully automate CMC report generation
• Developed by a team with more than 25 years of experience providing product development and technical SaaS solutions to the life sciences industry

Compass BIO is designed to scale with organizational needs, allowing teams to start with a single module and add additional modules over time. Its structured approach to CMC data management supports compliance with regulatory requirements while reducing manual effort and development costs.