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Core QMS

Core QMS

The FDA Has Issued its Final Rule on QMSR; Adopts ISO 13485

Core QMS

February 15th, 2024

10 min read

On January 31st, 2024, almost 2 years after the Food and Drug Administration (FDA) published its proposed rule for the harmonization of quality system regulation (QSR) and ISO 13485, it has issued its final rule.  Here’s what medical device organizations need to know.  What Is QMSR? The quality management system regulation (QMSR), which has been a...

What Is an eQMS? (and Why Life Sciences Organizations Need One)

Core QMS

February 8th, 2024

10 min read

The life sciences industry—from pharmaceuticals to biotechnology to medical devices—plays a pivotal role in ensuring global health. In order to do so, these organizations must comply with rigorous regulations and complex processes to ensure the products they deliver to market are at the highest standards of quality, safety and efficacy.  Organizations can effectively and efficiently...
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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,...

5 ways AI will change the life science industry

Core QMS

March 16th, 2023

10 min read

Artificial Intelligence (AI) has revolutionized many industries, and the life science industry is no exception. AI will change the way we discover, develop, and deliver healthcare. Here are five ways AI will change the life science industry: 1. Drug Discovery Drug discovery is a complex and expensive process that involves identifying potential drug targets, designing...

QMS 101: Quality Management System Guide

Core QMS

December 8th, 2022

12 min read

1. What is Quality Management System (QMS)?2. How Do Quality Management Systems Help Businesses Increase Profitability?3. Quality Management System Examples4. Dot Compliance eQMS Essential Elements5. Ensuring Compliance with ISO 9001, EU MDR, FDA & More6. Quality Management System Development7. The Bottom Line 1. What is Quality Management System (QMS)? A quality management system (QMS) is a...

QMS 101: Quality Management System (QMS) for Life Sciences

Core QMS

November 22nd, 2022

6 min read

Defining and formalizing a system that records processes, procedures, and roles for accomplishing quality policies and objectives is the main goal of a QMS in Life Sciences. In essence, it offers the framework for multiple organizational functions to collaborate and produce the highest-quality goods and services to the client. To find out the benchmark for...

8 Key Principles of Quality Management

Best Practices

October 18th, 2022

5 min read

The 8 Principles of Quality Management are the foundation for guiding QMS Principles of ISO 9001, the most widely adopted quality standard in the world. The International Organization for Standardization, or ISO, created these guidelines, which form the cornerstone of quality and compliance. ISO 9001 gives organizations an operational framework to develop processes and procedures...

QMS 101: Quality Management System (QMS) for Manufacturing

Core QMS

October 6th, 2022

5 min read

Manufacturers may electronically monitor, control, and record their quality processes with the use of a quality management system (QMS), which helps to verify that goods are produced within tolerance, in accordance with all relevant standards, and are free from defects. The techniques, processes, structures, and resources required for streamlining manufacturing and ERP operations while controlling...