Kaye Validator AVS - Electronic Data Requirements; The Study Setup

Chapter 1. The Kaye Validator AVS
Kaye Validator AVS User’s Manual 10
1.5.3 Electronic Data Requirements
The Validator AVS is designed to help you meet the guidelines for electronic
signatures as specified in FDA Regulation 21 CFR part 11, Electronic Records;
Electronic Signatures.
• Two levels of identification - user ID and password
• Uniqueness of each user ID
• Users create their own passwords
• User ID and password required whenever an action affects the security or integrity
of the data
• Electronic signature identifies the user, and includes the date and time of the action
• Data files are encrypted and can only accessed through the AVS software. If the
data is tampered with, the entire data file becomes inaccessible
• Password expiration feature allows you to set a password expiration
• System Administrators can set a minimum-password length requirement
• Option to disable a user account if there are three consecutive login failures for the
user ID
• Secure audit trail files provide a complete listing of events that affect the integrity of
the Validator AVS program and the Validator AVS instrument. Audit trail files
contain all events and identify the type of action performed, the date and time the
action occurred, the name of the responsible operator, and any additional
information required to understand the action taken.
1.5.4 The Study Setup
The study setup defines everything required to calibrate sensors and run a qualification
study. When you create a setup, you:
 Define the sensors you are going to use in the study
 Assign sensors to groups and specify group calculations
 Define group events to be monitored during the qualification study