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For life science companies, compliance with regulatory standards is paramount to ensure the safety, efficacy, and quality of products and processes. One such critical regulation is FDA CFR Part 11, which governs the use of electronic records and...
Tags: FDA compliance software, Quality Management System, 21 CFR compliance, Compliance, fda cfr part 11
If you want to ensure you are providing consistent products or services throughout your organization, you must implement an ironclad quality management system, or QMS. Quality control management ensures that what your company delivers, and the...
Tags: FDA compliance software, Quality Control Management, quality management, quality management software, quality management software systems
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
Is your company fully prepared to handle a compliance crisis? Effectively managing this process is no easy task, especially if you’re part of the highly regulated pharmaceutical industry. To make this process less daunting, it’s important to plan...
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
Artificial Intelligence (AI) and machine learning are the newest technologies revolutionizing the medical device industry. These advances have the potential to transform the way medical device companies gather important insights from the vast...
Tags: FDA compliance software, medical device document control, AI, Artificial Intelligence, medical device
Over the last few years the Food and Drug Administration (FDA) has become progressively more aggressive and tactful in the way they conduct their audits. More often than not, companies are unprepared to manage an FDA inspection or to effectively...
Tags: FDA compliance software, quality management software system, audit, fda audit
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