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