POMS MES for Biologics    

Executing the Process

The key to consistent execution is the system’s Interactive Process Director. The Interactive Process Director guides operators and equipment through the complex steps of biologics manufacturing and packaging, ensuring that process specifications are consistently executed and that errors are driven out of the process. Broad exception- and deviation-handling capabilities are provided, with support for multiple levels of escalation.

Other Process Execution Support:

• Campaign Management
• Materials Management
• Weigh and Dispense Operations
• Exception and Deviation Management
• Asset Tracking and Management
• Quality Data Management
• Sampling
• Data Input Source Discrimination
• FDA Electronic Signature Compliance (per 21 CFR Part 11)
• Complete Compliance Record
• KPI Measurements
• Materials Traceability and Genealogy
• PLC/DCS system recipe execution
• Process Data Historian
• Alarm and Event Management

Generation of EBR Compliance Record

POMS MES is unmatched by any other electronic batch record (EBR) solution in the industry, because of its ease of use and its comprehensive, integrated approach to batch record creation and management. As interactive process events occur, the POMS MES EBR compliance data is captured. Biologics processes are dynamic and complex; manual interventions or system anomalies that occur during process execution are identified and managed by POMS. Resultant compliance data captured during anomalies is captured in the EBR. The construction of the POMS MES EBR facilitates product ‘release by exception’, thus reducing the overall ‘Cost of Quality’ associated with compliance record quality reviews. Compliance capability, proper execution management, exception management, process data capture, data storage and execution event capture are at the heart of the POMS MES for biologics solution.

Integration with Enterprise Systems

POMS MES EAI Modules™ provide integration with Enterprise Resource Planning (ERP) systems, Supply Chain Planning systems, Laboratory Information Management Systems (LIMS), and Document Management Systems so you gain two-way communication between the plant and the rest of your enterprise. The translation of plant floor data to enterprise formats makes POMS MES extremely valuable, not only as a system for managing the plant and leveraging your supply chain, but also for providing information to executives for smarter, faster decision making.

Other Products in the Honeywell Biologics Product Line

Please examine the left side-bar list of other Honeywell products that complement the capabilities of the product described above.

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