(1888PressRelease)
March 24, 2006 - The FDA specifically states that the “agency expects the magnitude of these benefits should significantly outweigh the costs of making these system.” Easily obtained ROI include benefits derived from adhering to 21 CFR Part 11 regulations include:
• Reductions in system vulnerability and abuse
• Lower regulatory or compliance driven costs
• Shorten validation time
• Reductions in entry errors
• Reduction in costs related to record retention
• Improved data integration and modeling capabilities
• Advanced search capability via a decision support system and data warehouse
• Increased speed of information exchange
According to Rebecca Gill, Vice-President of Technology Group International, “Enterprise 21 is a fully integrated ERP (Enterprise Resource Planning) software package developed in a closed system approach. The software has built in controls necessary to obtain validation from the FDA.” Created by Food and Drugs Administration (FDA) in 1997, 21
CFR Part 11 requires FDA regulated companies to adhere to a specific set of requirements for computerized systems, electronic records, and electronic signatures.
21 CFR Part 11 requirements supported by Enterprise 21 ERP are extensive.
About Technology Group International, Ltd. Founded in 1990 and headquartered in Toledo, Ohio, Technology Group International is a proven technology leader delivering Tier 1 application software functionality at a price performance level that can be readily accepted by organizations of all sizes. Specializing in software solutions for small and mid-market manufacturing and distribution companies, TGI’s integrated Enterprise Series software suite is a complete business process management solution. The product offering includes Enterprise Resources 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 eCommerce. TGI implements, maintains, enhances, and supports its packaged distribution and manufacturing software solutions directly and via its channel partners.
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