| nts | | | | - Full data warehouse and ad hoc report writer for |
| Bioterrorism Act of 2002 Compliance Requirements | | | | fast and easy reporting |
| managed through Enterprise 21’s ERP | | | | According to Rebecca Gill, Vice-President of TGI, Ltd., |
| Software | | | | “Enterprise 21 is a fully integrated ERP (Enterprise |
| Created by Food and Drugs Administration (FDA) in | | | | Resource Planning) software package developed in a |
| 2002, the Bioterrorism Act of 2002 requires FDA | | | | closed system approach. The Bioterrorism Act of |
| regulated companies to adhere to a specific set of | | | | 2002 affects small, medium, and large companies |
| requirements for the establishment and maintenance | | | | alike. The required dates of compliance may vary by |
| of records. The scope of the regulation includes | | | | company size, but the requirements themselves stay |
| requirements for the establishment and maintenance | | | | the same. Compliance is not option, it is a |
| of records by persons who manufacture, process, | | | | mandate.” |
| pack, transport, distribute, receive, hold, or import | | | | About Technology Group International, Ltd. |
| food. The regulation dictates that companies be able | | | | Founded in 1990 and headquartered in Toledo, Ohio, |
| to produce records within four hours pertaining to | | | | Technology Group International is a proven |
| the manufacture, processing, packing, transporting, | | | | technology leader delivering Tier 1 application |
| distribution, receipt, holding, or importation of food | | | | software functionality at a price performance level |
| products. | | | | that can be readily accepted by organizations of all |
| Bioterrorism Act of 2002 Requirements Supported by | | | | sizes. Specializing in software solutions for small and |
| Enterprise 21: | | | | mid-market manufacturing and distribution companies, |
| - Design verification and validation of manufactured | | | | TGI’s integrated Enterprise Series software |
| product | | | | suite is a complete business process management |
| - Recipe management | | | | solution. The product offering includes Enterprise |
| - Routine manufacturing | | | | Resources Planning (ERP), Manufacturing Resource |
| - Engineering change order tracking | | | | Planning (MRP), Supply Chain Management (SCM), |
| - Component and supplier selection | | | | Warehouse Management System (WMS), Advanced |
| - Product labeling | | | | Planning and Scheduling (APS), Decision Support |
| - Testing and inspection | | | | System (DSS), Business Intelligence (BI), |
| - Document management | | | | Manufacturing Execution System (MES), and |
| - Complete raw material through finished good lot | | | | eCommerce. TGI implements, maintains, enhances, |
| tracking | | | | and supports its packaged distribution and |
| - Product distribution and tracking | | | | manufacturing software solutions directly and via its |
| - Recall management support | | | | channel partners. |