QMS 101: Pharmaceutical Quality Management System

The Pharmaceutical Quality Management System (QMS) is a collection of activities and processes that improve the quality of the pharmaceutical product. It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. For instance, data...

The Ultimate Guide to 21 CFR Part 11 QMS

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Organizations must abide by several rules and different sets of criteria that are specific to the life science...

The Ultimate Guide to ISO 9001

The Quality Management System (QMS) doesn’t have any independent standards. It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. It is the obligation of the firm to implement the pertinent standards, which vary depending on a variety of elements, such as location, product type, and target market....

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...

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.

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.

5 Necessary Steps for Building a Risk Assessment Framework

The life science sector is one of the country’s most lucrative industries. It’s currently worth $7.7 billion and is expected to attain a CAGR of 7.8% between 2021, and 2028.  But with huge rewards come huge risks, and the life science industries are abundant with them. From global volatility, intellectual property theft, to strict and...

Scope Creep: Four Basics for Avoiding It

Of all the KPIs monitored within the Life Science industry, scope creep during technology implementations has a tremendous  impact on overall company performance. Scope creep, also known as requirement or feature creep, refers to uncontrolled changes or continuous expansion in a project’s scope. It’s often inevitable. But, if your project stays within scope, other KPIs...