Released on: 20, March 2006
, Author: Rebecca Gill
, Audience: Software related
FDA specifically states that the  agency expects themagnitude of these benefits should significantly outweigh the costs of making thesesystem. Easily obtained ROI include benefits derived from adhering to 21 CFR Part11 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) softwarepackage developed in a closed system approach. The software has built in controlsnecessary to obtain validation from the FDA. Created by Food and DrugsAdministration (FDA) in 1997, 21 CFR Part 11 requires FDA regulated companies toadhere to a specific set of requirements for computerized systems, electronicrecords, 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 isa proven technology leader delivering Tier 1 application software functionality at aprice performance level that can be readily accepted by organizations of all sizes.Specializing in software solutions for small and mid-market manufacturing anddistribution companies, TGIÂ's integrated Enterprise Series software suite is acomplete business process management solution. The product offering includesEnterprise Resources Planning (ERP), Manufacturing Resource Planning (MRP), SupplyChain Management (SCM), Warehouse Management System (WMS), Advanced Planning andScheduling (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 softwaresolutions directly and via its channel partners.
Source: Express-Press-Release.com
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