BellHawk Systems assists is clients to implement pharmaceutical materials tracking and traceability systems. This includes labeling and tracking products subject to DSCSA serialization requirements.
These systems are used by mid-sized pharmaceutical and OTC product manufacturers, CMOs, repackagers, and other organizations subject to FDA regulations.
These systems are based on the use of the BellHawk software platform, which provides end-to-end materials tracking and traceability, including the capture of pedigree information for received products and the generation of pedigree information for products shipped to customers.
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 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. Through the use of the Bell-Connector software it 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 Systems is now adding the ability to generate GS1 EPCIS visibility event data for supply chain integration.
BellHawk Systems' team has significant experience in assisting mid-sized pharmaceutical and biotechnology processing organizations to implement FDA compliant systems. This includes assisting clients to understand FDA requirements and the implication of the underlying GS1 standards. It also includes systems design and implementation as well as providing systems validation assistance.
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