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A Comprehensive Guide to Writing SOPs

According to the FDA, inadequate standard operating procedures (SOPs) are one of the most frequently cited causes of non-compliance warning letters. And while a poorly written SOP can cause a multitude of additional major compliance problems, a...

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Tags: document control, FDA Compliant Document Control Software, fda guidelines, sop management, what are sops

Top FAQs on FDA 21 CFR Part 11 Compliance

As more companies move their processes into the digital space, new risks concerning the security of electronic records surface. In March of 1997, the United States Federal Food and Drug Administration (FDA) created CFR Part 11 to combat those...

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Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11

5 Tips for Complying with The FDA's Food Safety Modernization Act (FSMA)

According to recent data from the Centers for Disease Control and Prevention, about 48 million people in the U.S. get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. The recent changes to the FDA’s Food Safety...

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Tags: FDA compliance software, fda guidelines, food and beverage industry, fsma

How the Newest FDA Labeling Guidelines Will Affect Food & Beverage

How the Newest FDA Labeling Guidelines Will Affect the Food & Beverage Industry

The food and beverage industry faces constant regulatory challenges and is heavily scrutinized by the FDA. And with new labeling regulations coming down the pipeline, these expectations will only become more complex. In this article, we will...

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Tags: FDA compliance software, fda guidelines, food and beverage industry

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