A PC-Based Data Acquisition Program
Leak-Rx©, a MS-Windows based program developed at ATC, is a US-FDA 21CFR Part 11 compliant version of the Leak-Tek© software. Leak-Rx© is setup with a protected database and is essentially a user friendly data acquisition, analysis and monitoring platform that track user actions within the software. Leak-Rx© is a system that can only be used to configure sensors that are coupled with the software with an encrypted Key.
The following screens are some of the 21CFR Part 11 standard compliant features available with Leak-Rx©:
1 – Account Administration
User Account Setup features such as account expiration date, Enable/Disable accounts, access level permissions, unique combination of user names and passwords.
2 – Auditing Trail Printing
Time Stamped Records Export
All critical information from the software screens can be exported/printed with a Time Stamp and User Name.
3 – File Validity
Signature File Validation
Software warns the user if any data file (signature file) selected for viewing has been tampered with or altered.
4 – Audit Trail Query Builder
- The Leak-Rx© software logs time stamped user actions and sensor parameter changes.
- The Audit Trail Query builder is an intuitive, easy to use tool that allows users to view the audit trail by Parameter Type, Time Stamp, Setup ID, User ID or Sensor SN.
- A separate Audit Trail is maintained for each screen in Leak-Rx©.