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Thermo Fisher Scientific

269-114905 - Rev C - OMNIC Software 21 CFR Part 11 Compliance

This document outlines how Thermo Scientific OMNIC software with the DS option supports compliance with FDA 21 CFR Part 11 regulations for electronic records and signatures. It describes features like audit trails, digital signatures, secure access, data integrity, and role-based controls, while emphasizing that compliance also requires customer-implemented procedures and policies.

Description: 

This document explains how Thermo Scientific OMNIC Versions 8.3 (or higher) software can help users comply with the regulations in 21 CFR Part 11 for electronic records and electronic signatures

Environment:

OMNIC versions 8.3 or higher

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