All "Eqms" articles

5 secrets to securing medical device venture capital in 2023

 

What are the 5 best options for nonconformance management software in 2023?

 

5 benefits of a quality management system (QMS) in 2023

Implementing a quality management system (QMS) can offer noticeable benefits to your entire organization. Recognizing and communicating these ...

What's the best eQMS software in 2023? [Top 5 options]

An electronic quality management system (eQMS) doesn’t just make life easier for quality teams. As the life science world gets increasingly ...

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 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 ...

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.

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 ...

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 ...

The 5 Most Important Quality Equipment for Life Sciences Startups

What does it take to succeed as a life sciences startup? It’s a bit of a loaded question. Unfortunately, there isn’t a silver bullet to create ...

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 ...

Is Your Client Ready for the EU MDR Deadline?

COVID-19 introduced some amendments to the European Union Medical Device Regulation (MDR) application date. As such, applicants have until May 26, ...

CureMetrix Helps Radiologists Make Better, Faster Decisions With AI

It’s no secret the pandemic kept many people at home for the bulk of the last year.

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 ...

First Module of EUDAMED on Actor Registration Open

The European Commission has launched registration for the first module of the future European Medical Device Database. MDR EUDAMED is the first IT ...

5 Fundamentals of the CAPA Quality Process

The CAPA (corrective and preventative actions) quality system consists of the specific improvements an organization makes to its processes to ...

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 ...

How Much Does an ISO 9001 Quality Management System Cost?

Are you searching for an ISO 9001 quality management system but worried about overspending? If you choose a platform that's too costly and doesn't ...

Top 10 ISO 9001 Quality Management System Requirements

ISO 9001 certification can be a total game-changer for your business. So, what is ISO 9001? ISO 9001 standards are designed to help life science ...

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 Steps of a Quality Management Plan for Distributed Life Sciences Companies

If quality management is lacking within your distributed life sciences company, the success of your organization is in jeopardy. Without a quality ...

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 ...

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 ...

Single Sign-On With SAML2 Now Available for Qualio

While Qualio already has solid user permissions and digital signatures, some companies prefer to use the access control already in use by their ...

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 ...

EU Medical Device Regulation: Is Your eQMS Helping or Hurting?

Adjusting to regulatory changes like the new EU Medical Device Regulation can be difficult at every level. But is your eQMS making it even harder ...

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 ...

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 ...

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 ...

7 ISO 9001 Quality Management System Requirements & Benefits

An ISO 9001 certification can be a game-changer for your company. This quality certification opens the door for you to be able to sell your product ...

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 ...

What Are The 7 Best Online Quality Management Training Courses? [2022]

Quality management issues are responsible for an unfathomable amount of lost revenue. From production delays to recalls, product quality problems can ...

Is Your eQMS Built for ISO 14971 Risk Management Compliance?

Clearing the ISO 14971 risk management standard can be a pain without the right tools in place. One of the most difficult challenges to hurdle is ...

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 ...

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 ...

How to Enable Quality Controls in Life Sciences Marketing

Most life sciences companies are aware of the dangers of marketing noncompliance on their products. In recent years, major pharmaceutical ...

The Anatomy of a Healthy QMS for Life Sciences Companies

Ready to move on from a paper, hybrid, or legacy quality management system? Quality management system (QMS) software built specifically for life ...

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 ...

5 Indispensable Features Of Enterprise Quality Management Software

For enterprise organizations, enterprise quality management software (eQMS) is now the status quo. According to a recent market survey by LNS ...

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 ...

6 Essential Qualities of the Best eQMS Systems

We've found that life sciences companies look for enterprise quality management software (eQMS) systems for one of several reasons. Either they've ...

QMS in Pharma: 3 Safeguards to Ensure You Meet Compliance Guidelines

 

How to Implement a Document Management Process in the Age of HIPAA

Fine data trends can paint a partial picture of how the HIPAA compliance landscape is evolving. Last year, the HHS assessed $17.09 million in fines, ...

Understanding the Growing Need for Product Compliance Software

The life sciences industry is under an incredible amount of pressure from regulatory authorities, patients, and market conditions. Regulatory ...

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