When you need 21 CFR Part 11 compliance, Thermo Scientific VISIONsecurity™ makes your job easy. Integrating with your Windows® operating system, VISIONsecuritysoftware provides maximum security and data integrity assurance to your regulated laboratory. All files associated with VISIONsecurity are monitored and any changes are logged even when the software is not running.
Set up users only once; no need to configure each computer separately.
User and User Group settings are applied across all computers on the network automatically
Works in combination with Windows security to authenticate operators
Software access is controlled on a per user basis
Electronic Signatures
Establish record responsibility using user authentication and verification by a secondary observer
Assure the highest level of data integrity and aid in tampering detection
Complete Audit Trails
VISIONsecurity files are monitored continuously, even when the software is not running
Audit trail histories are not editable and stay with the data for added traceability
File events and program use are logged for administrative review
Flexible Record Storage and Retrieval
Original data is automatically saved to allow reproduction of results
Saved data is retrievable for use in VISIONsecurity software, or other third-party statistical or graphical analysis programs
Set system policies for VISIONsecurity™ software to:
Prevent overwriting of files
Save all raw data
Require digital signature on file saves
Require changing signature meanings when saving
Require reason when data is changed
Prevent changing directories when opening or saving files
User Authentication
VISIONsecurity software requires the use of a closed system to provide the appropriate level of security. It works with Windows security to re-authenticate the user's Windows account using Microsoft® authentication. Whenever the user launches VISIONsecurity or applies a digital signature to a file. This allows the system administrator to set policy settings for the computer through the server and eliminates the need to memorize different passwords.
Event Logging
System use and file event logging is reported in a custom Thermo Scientific log within the Microsoft Event Viewer. Information reported includes:
Changes to files associated with the VISIONsecurity software application, even when the software is not running, including file creation, modification, renaming, and deletion.
Changes to the Security Administration's application database
Activity of the Thermo Scientific Security Server
Program activity and detailed changes to files are tracked while VISIONsecurity software is running; including log-on, log-off and failed log-on; file signing and failed signing events and file creation or modification events
This comprehensive activity tracking and logging system assures you the ability to create detailed audit trails for your Thermo Scientific spectrophotometer, and the data it generates. Audit trails can be contained on a single workstation or run enterprise-wide by installing Thermo Scientific Security Administration as a server application.
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