POMS MES

Honeywell-POMS a Manufacturing Execution System that increases responsiveness of manufacturing by ensuring products are made and packaged the right way at the right time and at the lowest possible cost, every time. It allows users to control and track all aspects of production on the plant floor, enforcing cGMP while providing a complete history for compliance demonstration and performance improvements.

The software guides operators and equipment through every step of the manufacturing and packaging processes using an interactive step-by-step dialog, which provides instant feedback, verifies whether actions taken are correct and executed in the proper sequence, and determines whether additional action must be taken before continuing.

Master Batch/Device Record Creation
With it, process specialists create the complete Master/Batch Device Record or Recipe for a product-without learning programming skills. Changes can be made easily and immediately routed for approval. The Master Batch/Device Record contains all of the specifications required to make the product: labor, materials, facilities, equipment, and documentation.

Materials Management
The system provides comprehensive container-level tracking from materials receipt to the finished goods warehouse, manages associated quality data and the warehousing of materials in quarantine until lab results are available, tracks all work-in-process (WIP), and verifies quality control and expiration status of materials before use.

Weigh/Dispense Operations
The software supports fully automated weigh/dispense operations including direct interfaces to scales. It provides multiple dispense methods and tracks multiple materials and blends, or lots of the same material in a WIP container. The System automatically tracks and adjusts potency in the dispense room and provides instant dispense status.

Manufacturing and Packaging Operations
It provides comprehensive functionality to support the commercial manufacturing operations, including solid dose, liquids, creams, ointments, aerosols, medical devices, and biotechnology products. The key to consistent execution across operations is the Interactive Process Director. The Interactive Process Director guides operators and equipment through all of the steps of manufacturing and packaging, ensuring that the right specifications are consistently executed and that errors are driven out of the process. POMS MES also includes extensive exception and deviation handling, with support for multiple levels of escalation.

Measurements of Compliance and Performance
The system provides a tamper-proof batch record for compliance reporting, traceability, and analysis, and complies with all the requirements of 21 CFR Part 11. The compliance record is an exact, unalterable representation of all events that took place during production- an audit trail that includes all operator actions, including strike-throughs, signatures, data collected, deviations, and test results. By capturing all aspects of production in a unified history, the system also provides a comprehensive chronicle of Key Performance Indicators (KPI) that is a demonstrable measure of productivity and quality.

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