How Can Enterprise 21’s ERP Software Manage Bioterrorism Act of 2002 Compliance Requirements?
Created by Food and Drugs Administration (FDA) in 2002, the Bioterrorism Act of 2002 requires FDA regulated companies to adhere to a specific set of requirements for the establishment and maintenance of records. The scope of the regulation includes requirements for the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food. The regulation dictates that companies be able to produce records within four hours pertaining to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of food products.
Enterprise 21 is a fully integrated ERP software package developed in a closed system approach that has built in functionality and controls necessary to adhere to this FDA regulation.
What Bioterrorism Act of 2002 Requirements Does Enterprise 21 Support?
- Design verification and validation of manufactured product
- Recipe management
- Routine manufacturing
- Engineering change order tracking
- Component and supplier selection
- Product labeling
- Testing and inspection
- Document management
- Complete raw material through finished good lot tracking
- Product distribution and tracking
- Recall management support
- Full data warehouse and ad hoc report writer for fast and easy reporting
The Bioterrorism Act of 2002 affects small, medium, and large companies alike. The required dates of compliance may vary by company size, but the requirements themselves stay the same. Compliance is not option, it is a mandate.
To learn more about TGI’s Enterprise 21 software solution and FDA compliance, contact a sales representative at 800-837-0028.
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