The Part 11 Toolkit makes your existing Access databases compliant with 21 CFR Part 11. In one day, features are added to your Access program to track changes, control access and prevent unauthorized changes through password protection, audit trails, and electronic signatures.

The Part 11 Toolkit provides your Access database with:

Full Compliance with 21 CFR Part 11

• Limiting System Access (21 CFR 11.10d)
• Program Time-Outs (21 CFR 11.10d)
• Audit Trails (21 CFR 11.10e)
• Authority Checks (21 CFR 11.10g)
• Electronic Signatures (21 CFR 11, Subpart B)

MS Access Database Security

• All programs are password protected
• Unique Login ID's and Passwords are assigned to all users and required for all logins
• Customizable Password Requirements, set by your system administrators
• Multiple Levels of Security allows different parts of your program to be seen or updated by users with the appropriate credentials
  

Audit Trails for MS Access Databases

• Provides a complete change history for each record
  
• Event Logs record any event that occurs within the program, including logins, log-outs, error messages, or any other event specified by the program
  

Electronic Signatures for MS Access Databases

• Add to any form within your program
  
• Records are Locked from being updated once signed
  
• Developers may implement advanced features, such as batch signing of records
  

Search Engine with Customizable Results

• Included Search Engine allows users the ability to search for any records contained within your program
• Completely secure
• View search results in customized reports

Facilitates Computer Validation

Ofni Systems has proprietary tools which analyze how your database integrates with the Part 11 Toolkit and facilitates the generation of validation documents and testing protocols.

Special Offer! Ofni Systems will prepare free sample validation documents for your MS Access database to qualified purchasers. Contact Ofni Systems for details.