Catalyst eBMR is an advanced Electronic Batch Manufacturing Record (eBMR) system designed to digitize and streamline the batch production process within regulated industries, such as pharmaceuticals, biotechnology and healthcare. It provides a comprehensive platform for managing and documenting every step of the manufacturing process, ensuring compliance with regulatory standards (e.g., CPOB Aneks 7, 21 CFR Part 11, EU GMP Annex 11) while enhancing production efficiency and traceability.
Key Features:
1. Digital Workflow Management:
Catalyst eBMR offers a fully digital, paperless system for creating, managing, and executing batch manufacturing records. This enables real-time visibility of the manufacturing process and reduces manual errors associated with paper records.
2. Automated Data Collection:
The system integrates with various manufacturing equipment and instruments to automatically collect and record data throughout the production process. This automation enhances data accuracy and minimizes human intervention, which is critical for maintaining high product quality.
3. Compliance and Audit Readiness:
Catalyst eBMR ensures compliance with global regulatory requirements such as FDA 21 CFR Part 11 and EU Annex 11, providing electronic signatures, audit trails and version control. This guarantees that all modifications and approvals are traceable, supporting audit readiness at all times.
4. Recipe and Procedure Management:
The system allows users to define, store, and modify manufacturing recipes and procedures. These digital records help standardize operations across different production lines and batches, ensuring consistency and reducing variability.
5. Real-Time Monitoring and Alerts:
With Catalyst eBMR, production managers can monitor batch status in real-time, receive notifications for deviations or critical events and take corrective actions immediately. This proactive approach minimizes downtime and helps maintain high levels of operational efficiency.
6. Electronic Signatures and Approvals:
The system supports electronic signatures for batch review and approval, providing a secure, verifiable method for authorizing each phase of the production process. This reduces delays and facilitates faster batch release.
7. Integration with ERP and MES:
Catalyst eBMR seamlessly integrates with existing Enterprise Resource Planning (ERP) and Manufacturing Execution Systems (MES) to enable end-to-end process visibility, from raw material acquisition to finished product release.
8. Batch Record Review by Exception (RBE):
The system employs a Review by Exception model, which allows quality assurance teams to focus on non-conforming events and deviations, speeding up the batch release process.
9. Data Integrity and Security:
Catalyst eBMR prioritizes data integrity through robust security features, including encryption, access controls and detailed audit logs. This ensures that all data is protected against tampering and unauthorized access.
Benefits:
- Increased Operational Efficiency: By reducing manual data entry, automating data collection, and streamlining workflows, Catalyst eBMR shortens production cycles and boosts productivity.
- Enhanced Compliance: Built-in regulatory features ensure that all production processes meet industry standards, minimizing the risk of non-compliance.
- Improved Product Quality: Real-time monitoring and data accuracy lead to consistent product quality, reducing the likelihood of recalls or quality issues.
- Cost Savings: The system reduces paper usage, labor costs, and errors associated with manual processes, leading to significant cost savings for manufacturers.
In summary, Catalyst eBMR offers a comprehensive, compliant and efficient solution for managing batch records in highly regulated manufacturing environments. Its integration capabilities, real-time data collection and enhanced compliance features make it a critical tool for modernizing production operations.
