Molecular Spectroscopy Compliance

With every Thermo Fisher Scientific FT-IR, Raman, UV-Vis, and NIR instrument deployed in a regulated environment, you will receive a copy of the Thermo Scientific Security Administration software.  This tool uses Microsoft Windows security features to provide administrators a single point of control for all Thermo Fisher Scientific spectrometers which greatly reduces administrative overhead and guarantees consistent security policies for every user and instrument.

Developing, deploying and maintaining consistent security policies for compliance with regulations like 21 CFR Part 11 across multiple instruments using traditional software can be time consuming and prone to errors leading to inconsistent policies for users and instruments across the organization.

To solve this problem, we developed the Thermo Scientific Security Administration software.  This administration tool is a network-enabled program that is fully compatible with the Microsoft Windows domain and user account security system and provides a common environment for defining and managing security policies for all Thermo Fisher Scientific FT-IR, Raman, UV-Vis, and NIR software packages.  With this tool, system adminstrators get maximum control over all levels of security (including launching of software applications, operator access, electronic signature policies and data storage) with minimal effort.

The Thermo Scientific Security Administration software works in conjunction with your organization’s existing Windows security configuration, which greatly reduces the administrative overhead of regulatory compliance for each user and instrument and guarantees consistent policies are used though out your organization.  In addition, each instrument’s software includes an application security package which is automatically installed on the instrument’s computer that protects and tracks the critical data, method and other files (e.g. electronic records) from alteration and tampering, even when the instrument software is not running.

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• A single tool (one point of control, one user interface) is used for administering operator and system security for one to multiple Thermo Fisher Scientific molecular spectroscopy instruments, regardless of make or model.
• User identification, password and system access policies are based on your organization's existing Microsoft Windows domains and network security settings so that users only have one username and password to remember.
• Automatic tracking of all Thermo Fisher Scientific software user activity including administrative changes to security settings, operator logon/logoff, file signing and other security-related events.
• Automatic tracking of all activity on instrument-related files, even when the instrument software is not running!
• Application-only access to protected Windows folders allows data manipulation and file access to only occur via instrument software.
• Administrators have control over system security settings which are immediately enforced on all connected instruments, such as:
  • Define operator access permissions to run the instrument software, use individual software features, and use electronic signatures
  • Define operational controls for user activities (such as running experiments)
  • Configure events that require users to apply electronic signatures
  • Define specific meanings for electronic signatures
  • Configure data file storage and modification policies
    
    

FTIR & Raman:
OMNIC Software: 21 CFR Part 11 Compliance
OMNIC DS Software

NIR Analyzers:
RESULT Software: 21 CFR Part 11 Compliance
RESULT Software

UV-Vis:
VISIONsecurity Software: 21 CFR Part 11 Compliance
VISIONsecurity Software