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All "Eqms" articles

eQMS
• December 13, 2024

Qualio leaps to the front of the pack in integrated eQMS providers
eQMS
• December 13, 2024

What's the best eQMS software in 2025?
eQMS
• December 04, 2024

5 fundamentals of the CAPA quality process

The CAPA quality process, in a nutshell, consists of the specific improvements a regulated organization makes to its processes to eliminate defects ...
eQMS
• September 24, 2024

Q-Pulse vs. Qualio: a comprehensive guide to eQMS for life science companies
eQMS
• September 23, 2024

Qualio named Top Compliance Software for 2024
eQMS
• September 03, 2024

Our biggest product upgrade yet: UX, AI and more!
eQMS
• July 05, 2024

Faster, streamlined quality processes powered by AI in Qualio
eQMS
• June 10, 2024

Advancing the Qualio Way by cutting the stress from change management and simplifying custom event visibility and tracking
eQMS
• May 15, 2024

How to Manage the Med Device Software Development Process in Your eQMS

Managing the medical device software development process is a big undertaking. Software as a device is regulated like any other medical device, but ...
eQMS
• March 21, 2024

9 core elements of a quality management system [Examples]

Every life science company knows that quality is of the utmost importance. But defining quality and aligning that definition to regulations requires ...
Medical Devices
• March 20, 2024

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 ...
Medical Devices
• March 20, 2024

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. ...
eQMS
• March 14, 2024

Reinventing eQMS document management (and more!) in our biggest product release yet
eQMS
• March 04, 2024

CAPA management software: benefits, top features, and how to select the best
eQMS
• January 05, 2024

What are the 5 best options for nonconformance management software in 2024?
eQMS
• December 07, 2023

Making work even easier for our customers in our November Launch Train
eQMS
• August 10, 2023

Fresh features and time-saving shortcuts in our latest product release
FDA
• July 20, 2023

Guide to 21 CFR Part 11 compliance [free checklist]
eQMS
• June 14, 2023

Powerful quality analytic insights in our latest product launch
eQMS
• April 19, 2023

Faster access to your quality landscape with our latest product upgrades
eQMS
• March 03, 2023

5 secrets to securing medical device venture capital in 2023
Medical Devices
• July 05, 2022

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 ...
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 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 ...
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 start-up 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 ...
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 ...
Updates
• March 23, 2021

Qualio Ranks #1 in QMS Usability, Implementation, and Satisfaction on G2

Qualio has achieved the #1 spot in QMS implementation, usability, and momentum based on the responses of real users for each of G2's 2021 Spring ...
eQMS
• February 09, 2021

CureMetrix helps radiologists make better, faster decisions with AI
eQMS
• December 22, 2020

5 Essential Elements of Quality Management Software

The world's most broadly adopted standard, ISO 9001:2015, includes a series of quality principles that are frequently referenced in other QMS ...
FDA
• October 15, 2020

FDA to Issue New Guidance on QMS Validation: 4 Major Changes

Are you having difficulty validating a quality management system (QMS)? As you know, validation provides a level of confidence in the software's ...
eQMS
• September 03, 2020

What is eQMS Software Validation?

Before we dive into the specifics of electronic quality management system (eQMS) software validation, let's take a step back and briefly discuss why ...
Medical Devices
• August 25, 2020

5 Essential Elements of a QMS for Medical Devices

Are you planning on investing in a Quality Management System (eQMS) for your medical device company? Without careful consideration and planning, a ...
Certification
• July 02, 2020

How to Get a Quality Management Certification in 5 Simple Steps

Does getting a quality management certification keep you up at night? There's a lot at stake. Invest in the wrong certification and you might end up ...
eQMS
• May 14, 2020

5 Pharmaceutical Manufacturing and Quality Management Trends

Recently, studies have predicted that the value of the pharmaceutical industry will increase to $1.5 trillion by 2023. In anticipation of this ...
eQMS
• April 15, 2020

How to Set Up an ISO 14971 Risk Matrix in 5 Simple Steps

Without a solid ISO 14971 risk assessment methodology in place, defining risk can sometimes be like answering the question, "How big is big?" Listen ...
Quality Systems
• November 27, 2019

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 ...
eQMS
• October 24, 2019

How to Solve 5 Common Document Control Procedure Problems

We all have that drawer in our homes — the one filled with tangled cables, outdated gadgets, and random items that you just didn't have time to sort ...
eQMS
• September 05, 2019

9 Helpful Document Control Tips You Can Implement Right Now

As a life sciences company, how well you handle your document control can literally mean the difference between life and death. That may sound a tad ...
eQMS
• March 28, 2019

What Are The 4 Reasons You Need An Agile QMS? (And The Easiest Way to Get One)

An effective electronic (eQMS) can support all types of organizational transitions, whether you're scaling and need a more straightforward compliance ...
eQMS
• March 14, 2019

What You Need To Know About Part 11 Compliant Document Management Systems? (Top 4 Providers)

If your company is in a highly regulated industry—including pharma, medical devices, biotech, biologics, or CROs—you have to decide how to approach ...
eQMS
• November 29, 2018

13 Bottom Line-Boosting Benefits of a Quality Management System

Quality management system (QMS) software isn't an expense, it's an asset to life science companies. The key to achieving success with quality systems ...
iso9001
• September 28, 2016

5 Ways that a QMS Improves ISO 9001 Management

A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers
eQMS
• November 18, 2014

If it’s not documented, it didn’t happen