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Core QMS

Core QMS

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...
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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...

The Digital Culture Shift and Roadmap

Core QMS

August 8th, 2022

10 min read

As the life science industry recognizes how digital transformation can improve product quality and financial performance, there is a cultural shift occurring with QMS initiatives led by business and delivered by IT.  

Quality Management System (QMS) for Medical Device

Best Practices

June 16th, 2022

10 min read

In this post, we will take a deep dive into the medical device quality management system, look at the principal regulations governing the QMS, the difference between a QMS and an eQMS, and how a robust eQMS can solve the regulatory quagmire for medical device manufacturers.

Ready-to-use Quality and Compliance Solutions: Essential Tools for Regulated Industries

Core QMS

May 23rd, 2022

2 min read

In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization. Off the shelf solutions automate processes, mitigate risk, and enable business continuity while supporting employees and dispersed teams with the proper infrastructure.