How Can Enterprise 21’s ERP Software Manage 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.  The scope of the regulation includes requirements for storing, transmitting, and verifying electronic signatures. The regulation also dictates what conditions are needed to maintain data integrity of electronic information stored and modified in business management software packages or computer systems.

Enterprise 21 is a fully integrated ERP software package developed in a closed system approach. The software has built in controls necessary to obtain validation from the FDA.

What 21 CFR Part 11 Requirements Does Enterprise 21 Support?

• 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, date and time stamp, and data modified
• Data integrity protection
• Older data is not overwritten, but “inactivated” to prevent future usage
• Electronic signatures and approvals
• Procedural specific password requirements
• Online SOP (Standard Operating Procedures) availability
• Online field, screen, and procedure level help
• Online access of documents which are stored by data field or transaction
• Aged data may be accessible online indefinitely or archived in a controlled manner

What are the Benefits of Complying with 21 CFR Part 11?

The FDA specifically states that the “agency expects the magnitude of these benefits should significantly outweigh the costs of making these system.” In other words, the cost of purchasing an FDA compliant system is easily obtained in the system’s return on investment or ROI. Examples of 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

To learn more about TGI’s Enterprise 21 software solution and 21 CFR Part 11, contact a sales representative at 800-837-0028.