Molecular Spectroscopy Compliance

Be assured that your systems are configured to be fully complaint with the FDA 21 CFR Part 11, regardless of whether you are deploying one or more Thermo Fisher Scientific FT-IR, Raman, UV-Vis, or NIR instruments.

Thermo Fisher Scientific spectrometer software packages offer specific features that enable configurations that will fully meets the definition of a “Closed System” according to the 21 CFR Part 11 requirements.  These features cover all aspects of the FDA ruling, including:

• Validation and qualification of the entire system for operation
• Ability to discern altered/invalid records from valid records
• Provide accurate and complete records with full audit trails in both electronic and human readable form
• Maintain the security of stored electronic records
• Enforce operator authentication, system access, system usage and procedural controls

In addition, Thermo Fisher Scientific’s software compliance features enable organizations to fully utilize electronic records and signatures by providing:

• Unique operator identification throughout the entire company based on their Microsoft Windows domain user account
• Fully digital signatures which encapsulate the data being signed, the unique operator identity, the signature reason and the date & time of signing

Use any Thermo Fisher Scientific FT-IR, Raman, UV-Vis, or NIR software package in an FDA-regulated process, and be assured that it can be configured to fully comply with all requirements for a “Closed System” as defined by the 21 CFR part 11 regulations.

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