November 2017 Posts

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Practical Tips for Managing Supplier Risks in the Life Sciences Industry – Part 2

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Last week’s post was the first in a two-part series on practical tips for managing supplier risks in the life sciences industry. In the previous post we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
(more…)

Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Practical Tips for Managing Supplier Risks in the Life Sciences Industry

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions

Recently, I had the opportunity to explore practical tips for managing life sciences supplier risks along with Dr. Carmine Jabri of E.M.M.A. International Consulting Group, Aida Markham of QACV Consulting, and Kenneth Christie of VTS Consultants, Inc. This post is the first in a two-part series where we’ll review key takeaways from Pilgrim’s portion of that webinar and presentation. If you’d like to view the entire webinar, you can watch the on-demand version here.
(more…)

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

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.
(more…)

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

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.
(more…)