Enterprise 21’s ERP Software Manages FDA 21 CFR Part 11 Compliance Requirements

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.  According to Rebecca Gill, Vice-President of TGI, Ltd., “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.”

21 CFR Part 11 Requirements Supported by Enterprise 21 ERP:

• Unique identification and access of all users in the system
• User specific log in ID’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 cost center
• 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 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

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.

Technology Group International

www.tgiltd.com

Rebecca Gill

800-837-0028