This guide will help you understand the fundamental components of a Quality Management System (QMS) software and how QMS solutions are evolving to keep pace with business dynamics.

MasterControl is the foundation for connected quality data and complete product quality. It unifies applications, data, and documentation across your entire product development life cycle, from concept to commercialization. Go beyond proactive quality management and unleash the intelligence and insights concealed in unstructured data. Discover how the MasterControl Platform can make your vision of truly connected quality data a reality.

How adopting a data-driven and technology-supported approach to quality and product life cycle management can enable pharma and biotech organizations to not just survive, but thrive.

The digital documentation layer of quality and compliance processes is still critical and will never go away, but advanced technologies are helping life sciences organizations unlock the data side of the equation.

Explore the state of digital transformation in manufacturing and learn how you can extend your digital edge.

This ebook explores the current landscape of the medical device industry and the forces taking shape today that will drive growth into 2030 and beyond. From new technology to shifting patients’ experiences, we’ll explore how a wide range of issues are affecting product development and innovation, as well as the impact of digitization and data when it comes to device regulations and operations.

If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.

A significant challenge pharma companies that are striving to maintain compliance and get high-quality products to market quickly is corrective action/preventive action (CAPA) overload. Learn how to develop a smarter pharma CAPA management system.

We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.

Read more about quality management review regulations, a typical quality management review and how to ensure the reviews happen on schedule and per procedures.

Remote inspections can be easy if the company being audited has invested in a quality management system that stores its documents, provides version control, and tracks all changes.

With similar sounding terminologies it’s easy to misinterpret their definitions and misunderstand their purposes. Here we demystify the roles of each quality function, the ways they differ, and their impact on one another.

Read how to leverage manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse.

If your company is looking to purchase or develop medical device QMS software, you can’t afford to overlook these 10 most important system capabilities.

With the evolution of technology, 21 CFR Part 11 is more applicable than ever due to the increased use of digital technology for these quality management tasks.

Review the EUA transition guidances in more detail and learn how medical device manufacturers and other stakeholders can prepare for an orderly and transparent transition to normal regulated operations.

With so many manufacturing software products on the market today, evaluating and choosing the right one for your organization can be overwhelming. It doesn't have to be if you know the essential capabilities you need.

Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.

So few are poised to adopt a data-centric approach by using digitization, analytics, and AI that those who do will reap benefits from the data in their now unstructured documents.

Medical device companies that are working with inefficient or inaccessible systems can take these actions right now to positively affect their medical device regulatory strategy.

By adopting digital solutions today, manufacturers can capitalize on the opportunities of modern manufacturing solutions and realize their full potential.

Learn how to identify and choose a CMO that has a modern manufacturing solution, offer transparency throughout the entire production cycle, and can scale quickly.

Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.

It’s impractical to think that the medical device supply chain can be completely domestic, but there are steps that can be taken to deal with fluctuating COVID-19 protocols and transportation problems.

Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.

Medical device manufacturing is a complex industry, so figuring out what areas to digitize can be difficult and different for every company. Here we explore different ways medical device and diagnostic manufacturers are embracing digital tools to maximize the value of ever-increasing data, as the industry pivots from crisis mode to evolution.