Clinical Research Solutions
What are Quality Management Systems (QMS)?
What is Quality Management? Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all...
Quality & Compliance
Expanding EU & UK Market Access with eQMS & Manufacturer's Import Authorisation (MIA) License
This article has been updated since its original publication date. ProPharma holds its own MIA licenses both in the Netherlands to cover batch importation and Qualified Person (QP) batch...
Clinical Research Solutions
Top Challenges in Managing Your Product Quality Complaint Lifecycle
The Product Quality Complaint program is an essential tool in a company’s quality and compliance toolkit, not only for reducing patient risk and enhancing customer satisfaction, but because it...
Clinical Research Solutions
Critical Components of Quality Management Systems
Critical Components of Quality Management Systems: In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP), which must be compliant...
Clinical Research Solutions
ISO13485: The Importance of Management Review
ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the Quality Management System (QMS). Section 5...