POMS CMS

Honeywell-POMS a Clinical Manufacturing and Supplies system that directs and enforces current Good Manufacturing Practices (cGMP) and streamlines the production, packaging, labeling, and distribution of clinical supplies. The software also streamlines the transfer of formulation histories and master batch records to commercial production. The result is faster New Drug Approval (NDA) preparation and new product scale-up.

The software increases a clinical organization's ability to respond to medical and study sites, while reducing waste and costs, and ensuring compliance. With it, the right clinical supplies are produced, tracked, and delivered to the right investigation site.

Formulation & Recipe Creation and Management
With the software, process specialists create the complete formulation or recipe for a product-without learning programming skills. It is ideally suited for small, constantly changing formulations batches, batch sizes, and packaging requirements unique to clinical supplies.

Order Management
The software enables the creation, management, and scheduling of orders. It checks material availability and reserves materials for the study, and schedules equipment and assigns workcenters for the study.

Bulk Drug Substance Manufacture
The software provides comprehensive production order management, material management, and asset management functionality to support the production of active product compounds in bulk form.

Dosage Form Manufacture
The software provides comprehensive production order management, material management, and asset management functionality to support the transformation of bulk compounds into appropriate dosage forms for administration.

Package & Label
It manages the packaging and labeling of dosage forms into primary and secondary containers such as patient kits and patient blocks. The system includes comprehensive functionality for assembling, tracking, tracing, and reconciling all patient kits/packs. The software also tracks expired or cancelled study kits and reconciles labels.

Ship
It supports the distribution of packaged and labeled materials to investigational sites, interplant sites, and subcontractors. The system tracks all supplies and provides functionality for reconciling shipped materials and returns.

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