POMS CMS™ for Clinical Supplies Manufacturing

POMS CMS Functionality

Formulation and Recipe Creation and Management

You use the system to create the complete formulation or recipe for a product—without learning programming skills. The formulation and recipe author creates a general process to support multiple products or studies, then adds specific parameters to meet the requirements of each product, presentation or study.

You are able to specify, manage and track continuous changes in formulas and protocol setup, bills of material (BOMs), bills of equipment (BOEs), interactive work instructions, recipes, exceptions, and deviations. The solution allows for specification of and ensures in-process control and testing and prints and tracks in-process identity labels, so you maintain tighter process controls than ever before.

Bulk Drug Substance/Dosage Form Manufacture

POMS comprehensive functionality supports the specification and production of active product compounds in bulk form and the transformation of those compounds into appropriate dosage forms.

Request and Order Management

• Create and manage requests
• Allocate materials to requests
• Orders can be created directly or by converting requests to roders
• Manage, and schedule orders
• Check material availability and reserve/allocate materials to an order or batch
• Schedule and assign orders to work centers
• Create pick lists and dispense materials for specific orders or batches
• Handle exceptions initiated by both the system and the operator, with configurable review requirements

Materials Management

• Track lots of raw materials, samples, compounds, dosage forms, packaging components, labels, patient packages, containers, and work in progress using bar-code technology
• Manage every function, from receiving through sampling, status changes, movements, issues, adjustments, shipments, and reconciliation. You can also get reports immediately by material, lot, container and study.
• Manage the quality status, dates and potencies of materials from the point of reciept through distribution.
• Track genealogy from actives and excipients through final product

Asset Management

• View current status and cleaning history of rooms and equipment
• Automatically verify that scales are calibrated, standardized and operating within expiration dates.

Packaging and Labeling

The system manages the packaging and labeling of dosage forms into primary and secondary containers, and subsequently into patient packages. The system includes comprehensive functionality for specifiying, assembling, tracking, tracing and reconciling all patient packages.

You can print in-place labels (just-in-time) and batch labels, view images of patient kits for verification, and view images of labels for verification. You get a complete and instantly available genealogy of patient kits and blocks.

Shipping

The system controls and tracks the distribution of packaged and labeled materials to investigation sites, interplant sites and subcontractors. All supplies are tracked, with provision for reconciling shipped materials and returns. Clinical supply shipment is controlled and clinical materials must have appropriate approvals registered with the system before they can be shipped. Genealogy can even be tracked through subcontractors that do not have access to the POMS CMS system.

Reporting

You can capture all aspects of production in a tamper-proof electronic batch record for compliance reporting, including all operator actions, data collected from equipment, lab results, strikethroughs, deviations and exceptions.

The system provides forward and backward multi-level genealogy (e.g. actives or excipients into drug product, drug product into bottles or blisters, bottles or blisters into patient packages, and patient packages to investigators) You can also view status and transaction reports for both inventory and production orders. Additional capabilities include reporting on dispensing, expiration, shipping, asset history, and calibration.

POMS CMS™ Interfaces

The system’s open standards-based architecture supports integration with a variety of packaging label design and printing systems and with clinical trial management and clinical data management systems. Direct interfaces to scales, barcode scanners, and label printers are also supported.

POMS EAI Modules™ provide integration between POMS CMS and other systems, such as enterprise resource Planning (ERP) systems, supply chain planning (SCP) systems, laboratory information management systems (LIMS), and process and equipment control systems.

As a result, you gain two-way communication between your clinical operation and the rest of your supply chain.

Other Products in the Honeywell POMS Product Line

Please examine the left sidebar list of other Honeywell POMS products that complement the capabilities of the product described above.

Return to the Previous Page <