Top 6 Necessities You Need From Your eQMS Solution

Here are the eQMS features and benefits that you can’t go without in today’s complex and challenging business and regulatory environment.  

8 Key Principles of Quality Management

The 8 Principles of Quality Management are the foundation for guiding QMS Principles of ISO 9001, the most widely adopted quality standard in the world. The International Organization for Standardization, or ISO, created these guidelines, which form the cornerstone of quality and compliance. ISO 9001 gives organizations an operational framework to develop processes and procedures...

QMS 101: Medical Device Validation

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Regional regulatory organizations and worldwide standards, which frequently overlap when it comes to product needs, determine the requirements for validation and verification. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Quality assurance...

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 QMS

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...

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.