All "Eqms" articles

eQMS
• April 27, 2022

Outsourcing to a contract organization? You still need an eQMS. Here's why.

  I recently attended the American Biomanufacturing Summit in San Francisco. It sure was nice to be back in person! The company booth was lovely and, ...
eQMS
• February 22, 2022

Tips for moving from a paper-based QMS to an eQMS

Paper-based quality management systems have been a mainstay for life sciences organizations. A paper-based approach can be easy to stand up within an ...
eQMS
• February 10, 2022

Busting myths about eQMS vendors

“Are you guys certified to ISO 13485? How about ISO 14971? The IVDR transition period is about to end and the industry is scrambling, do you guys ...
eQMS
• February 03, 2022

The quality manager's guide to rapid eQMS success: validation, adoption and implementation

Electronic quality management systems (eQMS) were generally limited in their infancy to costly, custom on-premise platforms developed specifically ...
Case Studies
• January 25, 2022

How a quality assurance director freed up a week each month for continuous improvement using Qualio

New York-based Koneksa provides digital biomarker technologies for the remote capture of clinical trial data.
eQMS
• September 22, 2021

9 Core Elements of a Quality Management System (QMS)? [Real Examples]

 Listen to the audio version of this article about  9 Core Elements of a Quality Management System (QMS) read by a real person here (Sound on!):  ...
Quality Systems
• September 09, 2021

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 ...
eQMS
• August 12, 2021

How to respond to FDA warning letters

What’s the fastest way to ruin a quality manager’s day? Receiving a warning letter from the United States Food and Drug Administration (FDA). ...
eQMS
• July 22, 2021

Identifying the 4 Most Common Problems With Your CAPA Process

Over the years, we’ve heard from thousands of life sciences startup founders and quality managers. As an industry-leading quality management system ...
eQMS
• July 20, 2021

5 Major Total Quality Management Principles for Medical Device Startups

What is total quality management (TQM) as it relates to the life sciences industry? A bulletproof TQM strategy outlines the strategies manufacturers ...
Medical Devices
• June 29, 2021

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 ...
eQMS
• April 29, 2021

How to Build a Document Control Procedures Manual

How does your life sciences startup or scale-up manage its documentation? Unfortunately, ineffective document management can result in serious ...
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