Description

What is 21 CFR (Part 11)? 

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug regulations on electronic records and electronic signatures. It requires that a company implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data for processes that the FDA predicate rules require to be maintained for production and processing of food and pharmaceutical products.

What is Overlord Audit? 

Overlord Audit enables you to control and track the use of Overlord in your laboratory. Overlord Audit is a Kiosk system, developed to meet the documentation requirements defined in Good Laboratory Practice (GLP), as well as to fulfill 21 CFR (part 11) requirements. Cost-effective track and trace of every activity of any size laboratory automation system. The required electronic records are produced seamlessly and reliably with zero user input.

Functionality

Overlord Audit allows controlled access to the functionality of Harmony and Overlord although application operation is not affected. The Overlord Audit software will record and log all changes to files and directories in the file systems.  Specifically configured and implemented, Overlord Audit provides a highly efficient data integrity solution.

User Access

• Three user levels; Superuser, lab supervisor, and automation user
• Password must be changed at predefined intervals
• Screen saver can be configured for the same user of any qualified user to bring the system out of screen locked status
• Targeted restriction or elimination of user activities, applications, and changes to files and directories (local hard disks, USB drives, and network drives)

Validated environment

• Only superusers can make changes to the environment
• Superusers and lab supervisors can make changes to Harmony and Overlord settings
• Automation users can only run the validated processes
• Lockout the user from any or all other Windows applications

Electronic Signatures

• Only Superusers and lab supervisors can sign off results

Audit Trails

• Easy to use query dashboard to view information of interest
• All information is timestamped
• Stores changes (e.g. Overlord control procedures) made to protected programs
• Audit trail of WHEN, WHERE, and WHAT happens on your protected system
• Stores all login attempts

Summary

If you require any type of formal data integrity in your laboratory automation application, Overlord Audit is for you!