All "Quality Systems" articles

The ultimate guide to pharmaceutical quality assurance

Mastering quality management in laboratory environments: 12 essential techniques for 2024

Medical device quality management system template: 8 powerful options

Starting a medical device company is an immense task. You have plans to make, employees to hire, funding to obtain, and on top of all that, you have ...

Eulogy for Q. Emmess

Today, as Qualio publishes our 2022 life science quality trends report which reveals that almost half of quality professionals have already digitized ...

Quality Assurance vs. Quality Control Explained: 5 key differences

4 Examples of Continuous Improvement in Quality Management in Life Sciences Companies

We all know that quality management isn't a "set it and forget it system," but how do you actually make continuous improvement in quality management ...

The 13 Essentials of a Quality Plan for Medical Device Companies

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and ...

5 Quality Control Procedures for Life Sciences Startups

In recent years, there has been an increased focus on merging product innovation with product safety and quality. Without an intimate understanding ...

How to Solve the Four Most-Common Quality Management Issues? (2022)

Solving quality management issues keeps your life sciences organization on the right side of the FDA. However, compliance isn’t the only benefit. ...

What Are the Objectives [5 Examples] of Quality Assurance in the Pharmaceutical Industry?

When quality assurance in the pharmaceutical industry isn't prioritized, the results can be disastrous for the manufacturer and consumer. Imagine ...

The 3 Top Quality Assurance Conferences of 2020

In the last few months, the FDA has announced a few major changes designed to position the organization as a true leader in regulatory health ...

The 5 Best Pharmaceutical Quality Systems Changing Life Sciences in 2022

This year, industry-leading pharmaceutical companies will make significant investments in quality management systems. An effective quality management ...

14 Medical Device Quality Management System Requirements for Regulatory Compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

What To Consider When Choosing Quality Management Software (eQMS) for Medical Devices [8 Factors]

You already know that your current quality management system is hurting your medical device company — but how do you pick the right replacement? Your ...

Reviewing the Top Medical Device Quality Software Options for 2020

Times are changing and it’s getting harder and harder to keep up with ever-changing regulations using a paper-based quality management system. If ...

7 Signs You Need Pharmaceutical Quality Assurance Consulting

Quality Management Services: The 4 Essential Qualifications to Look For

Do you want to know what holds most young life sciences companies back from rapid growth? It's the false idea that you only have two options when ...

Life Sciences Quality Management System: 5 Must-Have Features & Functionality

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through ...

How to Create and Implement an Effective Quality System Plan

The life sciences company with the best product deserves to be at the top of the market. But how do you systematize quality throughout your ...

6 Signs Your Quality Management Process Is Failing

Is your company vulnerable to recalls, reputational damage, and regulatory issues because of quality management process problems? A single major ...

The Quality Policy of Pharmaceutical Industry Leaders Includes These 5 Things

Is a pharmaceutical quality policy just the necessary fine print that nobody reads? Not to industry leaders like Anders Vinther. Listen to the audio ...

How to Pass Every Quality Management Audit Without Breaking a Sweat

Over one million companies around the world have passed ISO certification. So, don't let a quality management audit scare you to death. Many quality ...

The 4 Worst Supplier Quality Management Procedure Problems for Life Sciences Organizations

Did you know that supplier quality management procedure issues have resulted in 1,111 citations by the FDA since 2008? 142 of those observances ...