5 Barriers to Enacting a Future-Ready Digital Quality Management

The evolution of quality over the past few decades from a regulatory and life science industry perspective has become more digital and streamlined to meet compliance and safety demands.  Regulators, clinicians, and patients demand that drug and device manufacturers instill quality throughout their product life cycles, across their organizations and out to third party suppliers. They...

ISO 17025 Checklist (with XLS Download)

One of the most significant limiting factors in the quality of a pharmaceutical, medical device, or other life sciences product is the quality of the laboratory where development and testing occurs. The way to ensure that your products meet the highest standards of quality and consistency — and convey your commitment to meeting these standards to customers and other parties — is to obtain ISO 17025 accreditation.

Quality Management System (QMS) for Medical Device

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.

5 Ways to Handle Change Control in Manufacturing

Here are 5 ways a manufacturer can equip its quality team with the real-time visibility and control required for effective change management.

The Complete Guide to X-bar Charts for Quality Control

While quality control tools take different forms, one of the oldest and most indispensable is the X-bar chart. Used in conjunction with its partner, the R-chart, the X-bar chart offers quality control personnel a way to analyze defects or variations of a process from a grouping of samples. This post takes a deep dive into quality control, quality control charts, and how using an X-bar chart can be a significant factor in achieving greater quality control of life science manufacturing.

A Guide to Medical Device Labeling Requirements

As an indispensable part of the medical device that ultimately ends up on the market, labeling is subject to FDA quality assurance requirements. These relate to the materials, operations, and controls of your labeling process, as well as the manner of application, inclusion in packaging, and other factors. To produce compliant labels, manufacturers have to manage, track, and update a significant amount of data.

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.