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Revolutionizing Complaint Management in Medical Device with AI-Integrated Quality Management Software

Artificial Intelligence

January 30th, 2024

10 min read

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. Complaint management plays a crucial role in identifying, addressing, and preventing issues related to product quality and patient safety. As technology continues to advance, the integration of artificial intelligence (AI) into quality management software solutions has emerged as...

Raising the Bar in Medical Device Compliance with Dot Compliance 

Regulatory Compliance

December 26th, 2023

10 min read

Welcome to the realm of regulatory excellence! In the intricate landscape of medical device manufacturing, regulatory compliance is not just a checkbox—it’s a commitment to ensuring the highest quality and safety standards. At Dot Compliance, we understand the pivotal role of compliance, especially with the stringent requirements outlined in 21 CFR Part 820. Navigating the...
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Navigating FDA Compliance: A Guide to 21 CFR Part 210 and Part 211

Regulatory Compliance

November 20th, 2023

10 min read

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. Manufacturers must adhere to stringent regulations set forth by the U.S. Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards.  For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210...

Unlocking Success: How the Right eQMS Can Be a Game Changer

Core QMS

September 27th, 2023

10 min read

In the highly regulated landscape of the life science industry, upholding uncompromising standards of quality is not just an option; it’s a necessity for achieving and sustaining success.  Whether you’re operating in the realms of pharmaceuticals, biotechnology, or medical devices, the quest to streamline operations, mitigate risks, and optimize efficiency is a constant pursuit.  Fortunately,...

The Evolution of Document Management Systems

Document Management

September 5th, 2023

10 min read

Embracing the digital age, modern Document Management systems have evolved into powerful tools that streamline and enhance how organizations handle their crucial information.  In this era where efficiency, collaboration, and compliance are paramount, these systems have become indispensable for businesses across the life science industry. In this post we dive into the intricate components that...

How to Choose the Right eQMS – The Ultimate Guide

Artificial Intelligence

August 8th, 2023

10 min read

In the highly regulated life sciences industry, quality management is crucial for ensuring product safety, regulatory compliance, and operational excellence. Choosing and implementing the right electronic quality management system (eQMS) is a strategic decision that can significantly impact your organization’s success.  This guide provides a step-by-step process to help life sciences professionals navigate the selection...

CAPA in the Age of Generative AI

Artificial Intelligence

May 11th, 2023

10 min read

Generative AI can revolutionize different processes in your business thanks to its many advantages. Once implemented, it can make your business more efficient, productive, and sustainable. Let’s go over some of its advantages:

How the use of AI is impacting life sciences manufacturing

Artificial Intelligence

April 14th, 2023

10 min read

The digital evolution of life sciences has opened the door to the implementation of advanced technologies. They are already revolutionizing how companies develop, manufacture and deliver products into the hands of clinicians and patients. Today, 45% of life sciences companies’ technology investments are made in three analytics-related technologies – applied AI, industrialized machine learning (ML),...