Composable MES for Pharmaceutical Manufacturing Overview

Introducing: The Composable MES for Pharma

In April 2024, Tulip released the Composable MES (cMES) App Suite to demonstrate how a foundational set of apps can be easily deployed and integrated into your daily operations for unmatched flexibility, agility, innovation, and faster time-to-value.

The Composable MES (cMES) for Pharma builds off the composable architecture of the Composable MES (cMES) App Suite for pharmaceutical manufacturers to scale their systems effortlessly. This app suite involves reusable, configurable components to tailor a standard solution to specific needs. This app suite accelerates digital transformation to expedite batch releases, improve quality, and ensure compliance for highly regulated environments.

Composable MES for Pharma Overview

The Composable MES for Pharma uses GxP best practices for the following solutions:

• Electronic Batch Records
• Electronic Logbooks
• Batch Production Management

The cMES for Pharma demonstrates how a modern, composable platform tackles today’s pharmaceutical manufacturing problems. The features of this app suite redefine how to approach digital transformation.

Data Structure

The applications in the cMES for Pharma use a unified data model to standardize data handling across multiple systems. This Common Data Model provides a structure to simplify creating, compiling, and analyzing various types of data. You can extend the common data model to solve unique problems.

See the full breakdown of tables in Common Data Model for Pharma here.

App Suites

The following app suites comprise the cMES for Pharma:

Electronic Batch Records

The Electronic Batch Record app suite focuses on digitizing and streamlining the batch record management processes. It helps to improve efficiency, accuracy, and compliance in recording and managing data related to batch production.

Goals of this app suite include:

• Workflow Automation: Automating data capture, notifications, and task assignments optimizes workflow efficiency, increases productivity, and standardizes processes. These improvements enable manufacturers to focus on core operations.

• Improved Regulatory Compliance: Ensuring adherence to regulatory standards by automating data capture, validation, and reporting, reduces the risk of non-compliance and errors in batch records.

• Streamlined Audits and Inspections: Easily access and present accurate, complete electronic batch records to enable quicker audits, inspections, and certifications. These improvements lead to operational efficiency and regulatory confidence.

Learn more about the Electronic Batch Record App Suite.

Electronic Logbooks

The Electronic Logbook App Suite focuses on streamlining data-logging processes and enabling comprehensive and efficient recording of information in real time (e.g. production activities, equipment statuses, incidents). By centralizing and digitizing logbook entries, this suite enhances visibility, compliance, and collaboration across the organization.

Goals of this app suite include:

• Efficient Data Capture: Simplify data entry and retrieval processes, enabling real-time logging of production activities, equipment status, and incidents for accurate and up-to-date records.

• Enhanced Visibility: Access logbook entries instantly, track operational activities, and monitor equipment performance. These improvements facilitate quick decision-making, issue resolution, and maintenance planning to improve operational efficiency and collaboration.

• Audit Trail Retrieval: Easily retrieve and review electronic logbook entries, timestamps, and user actions during audits and inspections. These improvements promote transparency, accountability, and streamlined audit processes.

Learn more about the Electronic Logbook App Suite.

Batch Production Management

The Batch Production Management App Suite focuses on providing real-time insights into batch production processes, enabling users to monitor equipment activity, track batch progress, and analyze productivity metrics through a dynamic production dashboard. It emphasizes promptly resolving open exceptions to optimize performance, expedite issue resolutions, and ensure that productivity aligns with production goals for streamlined batch production efficiency.

Goals of this app suite include:

• Real-time Production Monitoring: Monitor equipment activity, batch progress, and productivity metrics in real time, empowering informed decision-making that optimizes operations and ensures efficient resource management.

• Exception Management and Performance Tracking: Investigate open exceptions and performance metrics in real time, enabling swift issue resolution for faster batch releases. Stay informed on productivity status to align with production goals and drive operational efficiency.

• Mobile Accessibility for Operational Oversight: Facilitate real-time monitoring and control of production operations from any mobile device. Empower supervisors with on-the-go visibility into rooms, equipment, scales, and assets, enhancing operational oversight and responsiveness for streamlined processes.

Learn more about the Batch Production Management App Suite.

Further Reading

• A Summary of Tulip’s GxP Capabilities
• Best Practices for GxP App Building