BellHawk is an affordable CFR 21 Part 11 compliant system that can be used to track the manufacture, repackaging, and distribution of pharmaceutical products. It supports DSCSA Serialization tracking, including tracking serial numbers, printing barcode labels, and tracking which ingredients went into each batch of products.
BellHawk captures complete end-to-end traceability data to support tracking which ingredients went into which serialize products as well as the equipment and people involved. It also tracks how the products were packed and who they were shipped to.
BellHawk can track the receipt and put-away of ingredients by lot and serial number as well as tracking expiration dates and ensuring that quality control inspection is performed before the ingredients are used.
BellHawk can then track the picking of products for each batch, warning material handlers if the wrong materials are picked for the manufacture of a batch of materials.
BellHawk can generate DSCSA (Drug Supply Chain Safety Act) compliant barcode labels on a wide variety of barcode label printers.
BellHawk tracks serial numbers for products and can print out rolls of serial number labels for use in automated applicators or feed the serial numbers to automated labeling equipment in a process line.
BellHawk can then track which boxes each serial numbered product was placed into and which pallets the boxes were placed on. It can also record the picking of products for customer orders into mixed product boxes and pallets.
BellHawk is GS1 compliant and can generate ASN (Advanced Shipment Notice) data for transmission to customers by third party EDI applications. It can also receive ASN data from EDI applications for use in efficient receiving of materials.
BellHawk is available at an affordable cost on a subscription basis, in the Cloud, through our BellHawkRx service making it especially suitable for suitable for smaller biotechnology organizations and laboratories. BellHawk is also available on a rental basis for installation in a larger organization's own data center.
Please click here for more information about how BellHawk can ensure Compliance with FDA Data Collection Requirements.