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Custom Application for Biopharmaceutical Process Management and Collaboration

rolemodelsoftware.com

Medical

Manufacturing

Information technology

Challenges with Spreadsheet-Based Process Management

Existing spreadsheet-based systems hindered collaboration, version control, and accurate representation of complex biological/chemical processes. Lack of standardized material tracking delayed projects and created risks in pharmaceutical manufacturing workflows.

About the Client

Global Contract Development and Manufacturing Organization (CDMO) specializing in pharmaceutical manufacturing using cell line development and microbial fermentation

Digital Transformation Goals

Replace spreadsheet workflows with domain-specific application
Implement robust version control for Bills of Materials (BOMs)
Enable collaboration between scientists and supply chain teams
Standardize raw material usage across processes
Integrate with procurement systems for end-to-end visibility

Core System Capabilities

Raw material input and approval workflow
Version-controlled BOM generation at multiple process levels
Interactive version comparison tool
Collaboration features with role-based access controls
Integration points for procurement systems

Technology Stack Requirements

Ruby on Rails

Cloud-native architecture

Version control systems

System Integration Needs

ERP systems
Procurement platforms
Laboratory Information Management Systems (LIMS)

Operational Requirements

FDA 21 CFR Part 11 compliance
High-availability architecture
Role-based access control with audit trails
Scalable document version management
Real-time collaboration capabilities

Expected Business Outcomes

Reduced process development timelines through standardized material tracking, improved collaboration between R&D and supply chain teams, and automated BOM management. Enables procurement process automation while maintaining regulatory compliance in pharmaceutical manufacturing.