All "Eqms" articles

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 ...

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 ...

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 ...

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 ...

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. ...

Reinventing eQMS document management (and more!) in our biggest product release yet

What's the best eQMS software in 2024?

What are the 5 best options for nonconformance management software in 2024?

Making work even easier for our customers in our November Launch Train

Fresh features and time-saving shortcuts in our latest product release

Guide to 21 CFR Part 11 compliance [free checklist]

Powerful quality analytic insights in our latest product launch

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 ...

Faster access to your quality landscape with our latest product upgrades

5 secrets to securing medical device venture capital in 2023

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 ...

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 ...

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 ...

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 start-up 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 ...

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 ...

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 ...

CureMetrix helps radiologists make better, faster decisions with AI

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 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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

5 Ways that a QMS Improves ISO 9001 Management

A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers

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