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.  

Top 5 Life Sciences Technology Trends to Watch in 2023

To build greater resiliency into their supply chains, life sciences manufacturers need visibility into their suppliers’ operations so they can monitor the quality of their processes and materials. But 60% of life sciences supply chain executives struggle to get real-time inventory and visibility from external manufacturing partners, according to research from Accenture. To overcome these challenges and gain greater control over their supply chains, life science manufacturers are deploying quality management software that extends out to suppliers. With real-time visibility into supplier activities, manufacturers can proactively pivot when issues arise to mitigate risk and maintain manufacturing continuity.

QMS 101: Quality Management System Guide

1. What is Quality Management System (QMS)?2. How Do Quality Management Systems Help Businesses Increase Profitability?3. Quality Management System Examples4. Dot Compliance eQMS Essential Elements5. Ensuring Compliance with ISO 9001, EU MDR, FDA & More6. Quality Management System Development7. The Bottom Line 1. What is Quality Management System (QMS)? A quality management system (QMS) is a...

QMS 101: Quality Management System (QMS) for Life Sciences

Defining and formalizing a system that records processes, procedures, and roles for accomplishing quality policies and objectives is the main goal of a QMS in Life Sciences. In essence, it offers the framework for multiple organizational functions to collaborate and produce the highest-quality goods and services to the client. To find out the benchmark for...

Steps to Consider When Dealing With 483 FDA and Warning Letters

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. An FDA Form 483 Observation may concern the company’s building, tools, controls, procedures, goods, personnel conduct, or...

The FDA Ramps Up GMP Inspections

Your quality management processes are under the watchful eye of the FDA and other regulators, and it is only a matter of time until you are subject to an inspection, whether planned or unplanned. As the FDA ramps up its surveillance activities to address the COVID-19 pandemic backlog, the likelihood of an inspection grows. 

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...