Released on: 17, February 2006
, Author: Rebecca Gill
, Audience: Software related
Created by Food and Drugs Administration (FDA) in 1997, 21 CFRPart 11 requires FDA regulated companies to adhere to a specific set of requirementsfor computerized systems, electronic records, and electronic signatures. Accordingto Rebecca Gill, Vice-President of TGI, Ltd., Â Enterprise 21 is a fully integratedERP (Enterprise Resource Planning) software package developed in a closed systemapproach. The software has built in controls necessary to obtain validation from theFDA.Â
21 CFR Part 11 Requirements Supported by Enterprise 21 ERP: Unique identification and access of all users in the system  User specific log in IDÂ's and password for system access  User specific access to a given area within the system defined at a module,program, command, or field level  User specific access to system data based on company, division, group, or costcenter  Automatic audit trail created for entries and changes of data  Audit trail by user ID  Audit trail by date and time stamp  Audit trail by data modified  Data integrity protection  Older data is not overwritten  Older data is  inactivated to prevent future usage  Electronic signatures and approvals  Procedural specific password requirements  Online SOP (Standard Operating Procedures) availability  Online system help  Field level help  Screen level help  Procedure level help  Online access of documents which are stored by data field or transaction  Flexible data archiving  Aged data may be accessible online indefinitely  Aged data may be archived in a controlled manner The FDA specifically states that the  agency expects the magnitude of these benefitsshould significantly outweigh the costs of making these system. Easily obtained ROIinclude 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 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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