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Benefits of Total Environment Management...
Discover how a Total Environment Management (TEM) solution delivered by an Integrated Facility Automation System can both dramatically improve your business and uniquely enable 21 CFR Part 11 regulatory compliance.
In August of 1997, the Food and Drug Administration (FDA) placed into effect regulation 21 CFR Part 11 — a regulation which dictates the manner by which electronic records and signatures are to be captured, secured, retained, and retrieved.
The intent of this regulation was to help companies leverage the rapidly expanding role of paperless technologies within their facilities while maintaining and improving compliance with the rigorous quality and safety standards (Predicate Rules) required for pharmaceutical and biotechnology products as well as medical
devices. To better understand the implications of 21 CFR Part 11 and Total Environment Management download,
TAC's White Paper on the benefits of a totally Integrated Facility Automation System.
To view the paper,
please fill out the form below.
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