Kaye Validator AVS, Руководство пользователя

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Chapter 1. The Kaye Validator
1.5.3 Electronic Data Requirements
The Validator is designed to help you meet the guidelines for electronic signatures as
specified in FDA Regulation 21 CFR part 11, Electronic Records; Electronic Signatures.
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Two levels of identification - user ID and password
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Uniqueness of each user ID
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Users create their own passwords
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User ID and password required whenever an action affects the security or integrity of the
data
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Electronic signature identifies the user, and includes the date and time of the action
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If the data is tampered with, the entire data file becomes inaccessible
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Password expiration feature allows you to set a password expiration
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System Administrators can set a minimum-password length requirement
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Option to disable a user account if there are three consecutive login failures for the
user ID
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Secure audit trail files provide a complete listing of events that affect the integrity of the
Validator program and the Validator 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:
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Define the sensors you are going to use in the study
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Assign sensors to groups and specify group calculations
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Define group events to be monitored during the qualification study
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Specify calibration setpoints, temperature stability, and deviation criteria for sensor
calibration
Kaye Va
lidator User’s Manual
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