S Enterprise 21 ERP Software supports FDA 21 CFR Part 11 compliance requirements

S Enterprise 21 ERP Software supports FDA 21 CFR Part 11 compliance requirements Created by the Food and Drugs Administration (FDA) in 1997, 21 CFR Part 11 requires FDA regulated companies to comply with a set of requirements for computer systems and electronic records and electronic signatures. According to Rebecca Gill, Vice-President of TGI, Ltd., "Enterprise 21 is an integrated ERP (Enterprise Resource Planning), the software developed in a closed system approach. The software was built in the control needed to get approval by the FDA. "21 CFR Part 11 requirements supported by the enterprise 21 ERP: * unique identification and access for all users of the system * specific user access ID and password * for access to the system using specific access to a area within the system defined in a module, program, command, or on the ground, * the user access to specific data system based on the company, division, group or cost center * Automatic creation of a track control for entry and modification of data * Track checking the user ID * control time and control data * modified by * * the protection of the integrity of the historical data is not overwritten * old data is "inactive" to prevent future use * Electronic signatures and approvals requirements specific procedural * * password online SOP (Standard Operating Procedures) the availability of online help system * * Field Level Help Screen * * procedure to help the level of support for access on-line documents are stored * data or transaction data storage flexibility * mag * age data available on-line * age data can be stored indefinitely in a controlled manner, the FDA says that the agency expects the extent of these benefits should outweigh the cost of these systems. "easily won the retu on investment performance in comparison with 21 CFR Part 11 regulations include: * Reduce the vulnerability of systems and abuse * Low regulatory compliance or based on costs * Reduce the time of entry validation errors * Discounts * * reduce costs to improve the keeping of records of data and integration of modeling capabilities * advanced research through the ability to support the decision on the data warehouse system, and * Increase the speed of information about the exchange of technology Group Inteational Ltd, founded in 1990 and based in Toledo, Ohio, Technology Group Inteational is a leader in technology to provide level 1 application software functionality at a price at a level that can be readily accepted by organizations of all sizes. Specializing in software solutions for small and mid-market manufacturing and distribution, TGI integrated Enterprise Series software suite is a complete solution for managing business processes. The product offering includes Enterprise Resource Planning (ERP), Manufacturing Resource Planning (MRP), Supply Chain Management (SCM), Warehouse Management System (WMS), Advanced Planning and Scheduling (APS), Decision Support System (DSS), Business Intelligence (BI), Manufacturing Execution System (MES), and electronic commerce. TGI implements, maintains, strengthens and supports its packaging and distribution of manufacturing software solutions directly and through its channel partners. Technology Group Inteational 800-837-0028 Rebecca Gill