All "Eqms" articles

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, ...

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 ...

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 ...

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 ...

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.

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!):  ...

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 ...

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). ...

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 ...

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 ...

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 ...

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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