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.

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 brief provides an understanding of the key role corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement and offers a blueprint to help develop your own effective and optimized strategies.

With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.

We outline the steps to take before, during and after an FDA inspection so the FDA’s call to schedule an inspection doesn’t have to be a nightmare scenario.

Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

Learn practical steps that help pharma contract outsourcers exercise greater control over their supplier-related data, interactions, and processes and put them in a better position to cope with supply continuity challenges as they arise.

Learn how to gain a lead position in the market by digitally connecting and unifying all areas of your enterprise.

Suppliers and manufacturers working together to improve quality throughout the supply chain creates high quality standards to ensure final products are safe and effective.

We review commonly perceived barriers to adopting a traditional MES solution and how the path to digitization in manufacturing is easier than manufacturers might think.

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.

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

We review way to improve the manufacturing and quality assurance for gene and cell therapy products by using digital manufacturing execution systems (MES) and quality management systems (QMS).

Learn where modern manufacturing execution software can, and should, provide the essential functionality needed to address pharmaceutical and medical device manufacturers’ pressing production needs.

Product shortages — particularly pharmaceuticals — have imposed the heaviest toll on society. We outline recommendations for improving your pharma supply chain operations.

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

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.

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.

Here are some key concepts that the FDA deems critical for a discussion on modern quality systems and defines them within the scope of pharma manufacturing.

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.

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