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Whether your laboratory must comply with government regulations for full system validation, qualification and electronic records, or you have a quality system in place that requires documented evidence of system performance, Thermo Scientific FT-IR, NIR and Raman systems with OMNIC software offer the right mix of compliance tools. When your needs go beyond the standard performance verification capabilities offered in OMNIC, ValPro™ System Qualification and OMNIC DS Data Security with Thermo Security Administration Server offer best in class tools to meet or exceed any level of compliance requirements.

Complete Compliance Portfolio for Molecular Spectroscopy - Thermo Fisher Scientific offers a portfolio of solutions to meet your compliance needs.

Our portfolio includes:
• ISO Certified Quality System
• Complete System Qualification
• Certified Installation
• Custom Validation
• Operator Training
• 21 CFR Part 11 Compliance Tools

ValPro System Qualification exceeds the standard performance verification tests offered in OMNIC by providing Pharmacopoeial test methods, extensive documentation and procedures for DQ, IQ, and OQ, recommended PQ test protocols, plus control charts to track your system's performance.  With ValPro products and services, you can be confident that your system will provide accurate and consistent results throughout its lifetime and have the documented evidence required to prove it.

With the security and data integrity tools provided in OMNIC with the DS Data Security option, full 21 CFR Part 11 compliance can be readily achieved.  OMNIC DS using the Thermo Scientific Security Administration Server gives you 21 CFR Part 11 compliance without the hassle of many other instrument companies' offerings.

OMNIC DS works within the operating system's security environment to address the requirements of the regulation and for large enterprises with multiple systems, allows you to manage user policies over the network so system use is consistent.

Advantages of OMNIC DS

• No need to create new user names and passwords
  
• Digital signatures establish records responsibility and ensure data integrity, something electronic signatures can't do
  
• Spectral data audit trails and raw data storage travels with the data to provide traceability
  
• Unique log within the Windows Event Viewer tracks software use and OMNIC file events, even when OMNIC is not running