Document Management

Introduction to USFDA Form 483

USFDA Form 483, often known simply as "Form 483," is a critical document in the pharmaceutical and biotech sectors. Issued by the U.S. Food and Drug Administration (USFDA) after inspections, this form highlights observations regarding potential violations of the Federal Food, Drug, and Cosmetic Act. For companies regulated by the USFDA, receiving a Form 483 requires immediate attention and action. This article delves into what Form 483 is, and why it is issued?

Did you know An effective eDMS enhances compliance by centralizing and standardizing document management, reducing the risk of non-compliance by 40%. In the highly regulated life sciences industry, efficient document management is more than just a compliance requirement—it’s a strategic advantage. Regulatory affairs depend on timely, accurate submissions, and any misstep can lead to costly delays or non-compliance.

The fast-evolving and dynamic environment of the pharma industry calls for an equally active and quick technology. There is a rise in compliance technology due to various factors like robust regulatory adherence and efficiency in medical operations. There are various touchpoints and processes to keep in mind while dealing with the complexities of compliance regulations such as regulatory information management, compliance submissions, regulatory document management, and much more. This blog highlights the rising need for such technologies in today's Pharmaceutical Regulatory Affairs