Friday, 17 February 2017Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions
Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.
This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
Friday, 10 February 2017Bernard Jee, Product Manager, Pilgrim Quality Solutions
Nobody likes to hear complaints. When we do, our basic human instinct is to withdraw into our shell and stop listening. Unfortunately, in Life Sciences, ignoring a complaint can be a matter of life and death. And within any industry, the most expensive defect is a complaint from your customer. For this reason, ongoing communication flow is critical.
Friday, 03 February 2017Roxane Napoli, Senior Marketing Manager, Pilgrim Quality Solutions
Recently, Pilgrim co-sponsored a webinar with LNS Research titled “Supercharge Supplier Quality Management for Competitive Advantage.” During the webinar, Dan Jacobs, LNS Research Analyst, provided many insightful data points from his recent research and made the case for focusing on and advancing supplier quality maturity.
The data is clear…and compelling. Almost every organization can achieve significant gains by improving supplier quality management processes and maturity. If you haven’t watched the webinar, you can access it here
and see the data for yourself.
Friday, 27 January 2017Massimo 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.
Friday, 20 January 2017Rick Lowrey, CEO, Pilgrim Quality Solutions
In recent posts, we’ve dug into the need to transform your quality management system
and even how to extend quality management processes
outside the four walls of your organization. Each of these themes leads to a final goal; you will need to use the power of an automated, integrated Enterprise Quality Management System (EQMS) to achieve a mature, global quality system.
Our recent infographic details some of the typical paths that organizations take to achieve the benefits of automated, global EQMS. These end goal benefits include process and data harmonization, structured organizational hierarchies, enterprise integration, extended supply chain management, and a significant reduction in overall cost of quality.