The BellHawkRx Pharmaceutical Operations Tracking and Traceability System (POTTS) bundle provides a low-cost and easy-to-use Cloud-based solution that enables small to mid-sized organizations to comply with FDA materials tracking and traceability requirements.
POTTS is suitable for use by small to mid-sized manufacturers of pharmaceutical products, such as CMOs, makers of OTC pharmaceutical products, repackagers, as well as biotechnology and specialty manufacturers of pharmaceutical products in limited quantities. With the addition of WMS, the BellHawkRx Warehouse Management option, POTTS is also suitable for use by distributors that purchase pharmaceuticals in bulk but distribute these to their customers in small volume.
POTTS captures end-to-end materials tracking and traceability data to enable sending pedigree data to customers and data repositories by means of EDI or EPCIS data transmission.
POTTS replaces the use of paper forms and manual keyboard data entry with the use of barcode technology to reduce the amount of labor required for record keeping as well as preventing mistakes.
With the addition of the BellHawk Label Printing System (BLPS), within a facility, POTTS can print out DSCSA (Drug Supply Chain Safety Act) compliant 2D barcodes for application to bottles and cartons of pharmaceutical products using automated applicators or manual application.
POTTS can also print GS1 compliant barcodes on demand for application to boxes in which products are packed for shipment and shrink-wrapped pallets on which the boxes are stacked.
POTTS was developed to be compliant with CFR 21 Part 11 requirements and a data package can be made available to facilitate certification of the system to be in compliance with FDA good manufacturing practices.
POTTS is specifically designed for use by small to mid-sized organization and costs much less to implement than using materials tracking and traceability systems designed for use by large pharmaceutical organizations.
Please click here to learn more about the Tracking and Traceability Capabilities of POTTS.