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Melanie Sena is community editor of Pharmaceutical Technology.
Work-in-Process Tracking Software
BellHawk Systems’ 21 CFR Part 11 compliance module enables the use of the BellHawk inventory and work-in-process tracking software in manufacturing and distribution applications that need to comply with FDA GMP. The complete CFR 21 Part 11 compliant inventory and work-in-process tracking system is available for a monthy fee per management user or shared barcode scanning device. This software can be installed on a Windows server at the client’s facility or used at a secure data center. BellHawk makes use of barcode scanning and wireless mobile computers to track materials from receiving, through quality assurance, to production processing, to shipment to the end customer. It can handle formulas and batch records and builds a complete traceability history enabling one-step-back, one-step-forward tracking of the source of defects and the disposition of the resultant defective products.