| nts | | | | - Online access of documents which are stored by |
| FDA 21 CFR Part 11 Compliance Requirements | | | | data field or transaction |
| included in Enterprise 21’s ERP Software | | | | - Flexible data archiving |
| Created by Food and Drugs Administration (FDA) in | | | | - Aged data may be accessible online indefinitely |
| 1997, 21 CFR Part 11 requires FDA regulated | | | | - Aged data may be archived in a controlled manner |
| companies to adhere to a specific set of | | | | The FDA specifically states that the agency |
| requirements for computerized systems, electronic | | | | expects the magnitude of these benefits should |
| records, and electronic signatures. According to | | | | significantly outweigh the costs of making these |
| Rebecca Gill, Vice-President of TGI, Ltd., | | | | system. Easily obtained ROI include benefits |
| Enterprise 21 is a fully integrated ERP (Enterprise | | | | derived from adhering to 21 CFR part 11 regulations |
| Resource Planning) software package developed in a | | | | include: |
| closed system approach. The software has built in | | | | - Reductions in system vulnerability and abuse |
| controls necessary to obtain validation from the | | | | - Lower regulatory or compliance driven costs |
| FDA. | | | | - Shorten validation time |
| 21 CFR Part 11 Requirements Supported by | | | | - Reductions in entry errors |
| Enterprise 21 ERP: | | | | - Reduction in costs related to record retention |
| - Unique identification and access of all users in the | | | | - Improved data integration and modeling capabilities |
| system | | | | - Advanced search capability via a decision support |
| - User specific log in ID’s and password for | | | | system and data warehouse |
| system access | | | | - Increased speed of information exchange |
| - User specific access to a given area within the | | | | About Technology Group International, Ltd. |
| system defined at a module, program, command, or | | | | Founded in 1990 and headquartered in Toledo, Ohio, |
| field level | | | | Technology Group International is a proven |
| - User specific access to system data based on | | | | technology leader delivering Tier 1 application |
| company, division, group, or cost center | | | | software functionality at a price performance level |
| - Automatic audit trail created for entries and | | | | that can be readily accepted by organizations of all |
| changes of data | | | | sizes. Specializing in software solutions for small and |
| - Audit trail by user ID | | | | mid-market manufacturing and distribution companies, |
| - Audit trail by date and time stamp | | | | TGI’s integrated Enterprise Series software |
| - Audit trail by data modified | | | | suite is a complete business process management |
| - Data integrity protection | | | | solution. The product offering includes Enterprise |
| - Older data is not overwritten | | | | Resources Planning (ERP), Manufacturing Resource |
| - Older data is inactivated to prevent future | | | | Planning (MRP), Supply Chain Management (SCM), |
| usage | | | | Warehouse Management System (WMS), Advanced |
| - Electronic signatures and approvals | | | | Planning and Scheduling (APS), Decision Support |
| - Procedural specific password requirements | | | | System (DSS), Business Intelligence (BI), |
| - Online SOP (Standard Operating Procedures) | | | | Manufacturing Execution System (MES), and |
| availability | | | | eCommerce. TGI implements, maintains, enhances, |
| - Online system help | | | | and supports its packaged distribution and |
| - Field level help | | | | manufacturing software solutions directly and via its |
| - Screen level help | | | | channel partners. |
| - Procedure level help | | | | |