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....

The Essential Guide to ISO 13485 for Medical Device

ISO 13485 outlines the specifications for quality management systems (QMS) for medical devices. Both internal audits and external auditors (typically notified bodies) will test the validity of the quality management system. A medical device can be as simple as a first aid bandage or as complex as a pacemaker on which a patient’s life is...

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.  

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.

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.