November 2017 Posts

FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

FDA Gateway System Updates: The Continuing Evolution of eMDR Submissions

Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company

The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv, this information may not be readily available unless you visit the FDA Gateway website to see the full list of the planned updates.

In the interim, there are key updates that will impact various components of the submissions process.
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Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Get Quality in the Loop: 5 Key Processes to Integrate with Your Quality Management System (QMS)

Massimo Franza, Senior Director of Software Engineering, Pilgrim Quality Solutions, an IQVIA company

Think about your quality system. When you initially automate a quality process, you begin by determining the ideal process flow, data you wish to capture, check points to be recorded, and how information should flow between members of your team.

But what about the intersection of where a quality process ends and another business process begins? Some of these intersections may be critical checkpoints between quality and compliance processes and the rest of your business. Notifying Quality about customer complaints, updating Production with nonconformance dispositions, or providing access to documents that need to be referenced from quality records are just a few of the examples of where quality systems interacts with the rest of the business in real-time.
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