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A Guide to Medical Device Labeling Requirements

Medical Device Manufacturing

April 12th, 2022

5 min read

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

Best Practices

March 30th, 2022

6 min read

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.
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The Essential Guide to ISO 14971

Medical Device Manufacturing

March 25th, 2022

8 min read

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

Regulatory Compliance

March 22nd, 2022

3 min read

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).”

Top 10 QMS Software Benefits for 2022 by Industry

Quality 4.0

March 20th, 2022

10 min read

Quality is the first thing that people check when choosing something. Whether it’s a product, service or even a relationship, humans measure by two supreme factors — value and quality. When it comes to manufacturers, quality assurance is crucial if you want to stay competitive — not only because the quality is what people seek...

How to Choose the Best QMS for Life Science Manufacturers

Core QMS

March 17th, 2022

3 min read

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. 

Steps for a Successful Life Science Quality Audit – Part 2

Audit

March 1st, 2022

5 min read

In the first blog of this series, we outlined steps that a life science manufacturer should take to conduct an efficient but comprehensive internal audit of its quality operations. In this post, we explain how a manufacturer can leverage the fundamentals of internal audit planning for external audit success. 

Steps for a Successful Life Science Quality Audit – Part 1

Audit

February 22nd, 2022

5 min read

In part one of this two-part blog post series, we outline steps for conducting a proactive, internal audit to identify opportunities for continuous quality improvement and prepare for an external audit.