Chapter 5: File Management
ValProbe RT User Manual 55
Chapter 5. File Management
5.1. Overview
As a dedicated validation system, the ValProbe RT system is responsible for the collection,
reporting and storage of GxP files related to Thermal Validation studies. Data which is
collected by the ValProbe RT system is stored locally as raw encrypted data files along with
.pdf files of the reports used for analysis.
To meet Data Integrity, and 21 CFR Part 11 requirements, Kaye has designed the ValProbe
RT Console / software with the following features to protect data stored in the Console /
software:
• Dedicated Console and core load with only programs necessary to perform validation
activities (no internet access, e-mails, Microsoft office).
• Restricted access to modify or delete files/ date-time using Windows 10 LTSC OS and
permission rights for Operators.
• Ability for IT to download Virus protection programs and perform manual patches of OS.
• File Management tools which include the ability to Sync Out / Sync In and Archive all
data to defined paths such as share folder and mapped drives on the Domain.
The sync functions are used for a backup but also to merge the data of several console’s data
sets following some rules for merging:
• Preferences and policies are not synchronized.
• If two items with the same name exist, the item is updated with the latest version
(depending on the modified date) for Users and assets. If two items have the same
name but different dates (reports, study files), both are retained.
Sync operations are manually generated and started from the File Management tile on the
Main screen. Access to the File Management feature is controlled by User privileges defined
in User Management.
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