Manufacturing Excellence Platform

The TrackWise Manufacturing Excellence Platform is an advanced Manufacturing Execution System (MES) designed to transform life sciences manufacturing. It provides a modular and scalable solution that enhances operational efficiency and compliance through real-time insights and seamless integration with existing ERP systems.

This adaptive MES system facilitates agile and scalable operations for manufacturers of varying sizes and complexities. It simplifies implementation by requiring no programming knowledge, thus accelerating digital transformation and providing a rapid return on investment.

Key Features

• Electronic Batch Records (EBR): Digitizes paper-based recipes and procedures, automates execution, and generates electronic records to support audits.
• eLogbooks: Eliminates paper logbooks, making information instantly available for analysis.
• Recipe Authoring: Centralizes recipe management, ensuring consistency and compliance with a single source of truth for master batch records and procedures.
• Real-Time Production Visualization: Offers a comprehensive view of production processes, enabling faster decision-making and minimizing delays.
• Digitized Workflows: Replaces paper-based records with digital versions to support adherence to SOPs and streamline validation.
• Faster Batch Review and Release: Streamlines batch validation with review-by-exception functionality, reducing operator actions and signatures.

The platform supports regulatory compliance with guidelines such as 21 CFR Part 11 and cGMP, providing real-time visibility of material inventory and the dispensing process. It is designed to scale across manufacturing operations of any size, supporting seamless orchestration and optimization.

Advanced Capabilities

• Comprehensive Batch Execution Summary: Provides real-time information on equipment usage and operational phases.
• Equipment and Process Unit Tracking: Offers insights into equipment performance and process unit status.
• Production Orchestration: Automates workflows and integrates digital work instructions for consistency.
• Process Monitoring and Alerts: Allows operators to monitor critical parameters and receive alerts for deviations.
• Drill-Down Reporting and Analysis: Provides detailed reporting tools for trend analysis and process optimization.
• Seamless Integration: Integrates with SAP, TrackWise Digital QMS, Experion DCS, and other systems.
• Real-Time Exception Identification: Facilitates quick identification and resolution of production exceptions.

The platform also offers end-to-end process digitization, ensuring traceability and compliance, and supports recipe authoring and management to maintain accurate batch execution specifications. By integrating with the TrackWise Quality suite, it unifies quality and manufacturing data, optimizing processes and facilitating timely decision-making.