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New 2023 Pharmaceutical Guidelines: Ensuring Compliance with the Drug Supply Chain Security Act (DSCSA)
Tags: pharmaceutical, pharmaceutical industry document control, fda guidelines, Drug Supply Chain Security Act
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...
Tags: document control, FDA Compliant Document Control Software, fda guidelines, sop management, what are sops
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...
Tags: FDA Compliant Document Control Software, Compliance, fda guidelines, fda cfr part 11
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...
Tags: FDA compliance software, fda guidelines, food and beverage industry, fsma
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...
Tags: FDA compliance software, fda guidelines, food and beverage industry