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.

We take a closer look into how the industry will respond to an upcoming FDA guidance on cybersecurity in medical devices regarding quality system considerations and content of rremarket submissions.

QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.

Learn how Northeast Scientific digitized and integrated our quality and manufacturing processes to help obtain 510(k) clearance from the FDA for the first and only reprocessed laser atherectomy catheter in the history of reprocessing.

As a pharmaceutical product manufacturer, you regularly deal with a lot of processes, phases, and moving parts along the supply chain to get your products to market. The pharmaceutical industry is complex and highly competitive. It has become essential to seek out ways to scale, improve processes, minimize errors, reduce lead times, and keep quality and compliance at the top of the priority list.

We share how to get the most out of documenting your quality management system that can also help you stick to ISO 9001 standards.

While all enterprise software implementations are unique we share six best practices that will improve the likelihood of any successful quality management software implementation project.

We share tips on how to implement an eDHR system that allows you to capture and leverage all the data needed to optimize production while ensuring compliance with FDA 21 CFR Part 820 requirements.

In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.

For manufacturing organizations that haven’t fully digitized their production processes because of the high cost and complexity of conventional MES solutions, it’s time to put those fears to rest. This industry brief explores and dispels six common misconceptions of adopting MES in life sciences manufacturing.

We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.

While CSV can be a pain to deal with, it is necessary. Explore our eight best practices that can reduce validation time to a matter of hours or minutes.

We answer frequently asked questions to provide background on the intent of the QSR and should shed light on the FDA's perspective of the verification vs. validation conundrum.

Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization. 

Learn how to significantly lighten the software validation load for your cloud environment system with these eight key practices. 

Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.

This guide explains what a truly connected, paperless environment looks like while using Manufacturing Excellence.

Learn about the critical questions to ask while planning medical device audit management activities, as well as the five common problem areas with medical device quality system auditing. 

Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships. 

This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help 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.