The Digital Culture Shift and Roadmap

As the life science industry recognizes how digital transformation can improve product quality and financial performance, there is a cultural shift occurring with QMS initiatives led by business and delivered by IT.  

Medical Device Quality Management System (QMS)

In this post, we will take a deep dive into the medical device quality management system, look at the principal regulations governing the QMS, the difference between a QMS and an eQMS, and how a robust eQMS can solve the regulatory quagmire for medical device manufacturers.

Ready-to-use Quality and Compliance Solutions: Essential Tools for Regulated Industries

In the life science industry, many companies are recognizing that compliance is not hindered when leveraging pre-configured software technology to accelerate digitization. Off the shelf solutions automate processes, mitigate risk, and enable business continuity while supporting employees and dispersed teams with the proper infrastructure.

What is a Pareto Diagram, and How to Use It

Pareto diagrams provide graphical analysis for life science quality managers - showing how much each cause contributes to an outcome or effect. The Pareto chart is a quality improvement tool that is based upon the Pareto principle, the principle that 80% of an outcome comes from 20% of its inputs.

How to Choose the Best QMS for Life Science Manufacturers

There are many factors manufacturers have to take into consideration when evaluating a Quality Management Solution (QMS) to fit their growing business needs. They have to define the “critical components,” the “must haves” and the “nice to haves”. All while keeping in mind that compliance to regulations and global standards are non-negotiable, especially in the highly regulated life science and biotech industries. Here are key points to consider when selecting a QMS solution to support your company’s quality, compliance and growth. 

Align Supplier Quality Management with Digital Transformation Strategy

While life science manufacturers are pursuing digital transformation across many areas of their operations, its use for supplier quality management (SQM) is critical to product quality and patient safety given the current business climate.

QMS and the ICH Q10 Pharmaceutical Quality System

The stakes for quality management are high when it comes to the life science industry. As a result, pharmaceutical companies of all sizes need quality management systems built to address a slew of unique challenges and regulatory oversight. The key framework for creating a QMS that can handle the demands of the pharmaceutical industry is the International Conference on Harmonisation (ICH) Q10 model.

5 Considerations for an eQMS in Life Sciences

If you are considering an electronic Quality Management System (eQMS) to manage quality events and activities, deciding what is important to your organization will help determine which vendor and system are the right fit. Here are a few things to consider during the selection process. Defining organizational requirements for eQMS It is important to determine...