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 Clinical Management

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.

The Essential Guide to ISO 14971

The International Organization for Standardization created ISO 14971 to assist medtech manufacturers in developing processes for evaluating, monitoring and controlling the risk that their products could cause harm to patients, operators, or other individuals. ISO 14971:2019 is the third and most recent edition of the standard.

FDA’s Quality Metrics Reporting Update March 2022

On March 9, 2022 FDA provided an update on the Quality Metrics for Drug Manufacturing initiative. “FDA established a docket to solicit comments on changes to FDA’s previously proposed quality metrics reporting program (QM reporting program).”

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.