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Thought Leadership

Browse through this hub for company-related and industry-wide news. You’ll find blogs that highlight the latest hot topics impacting quality and compliance in the Life Sciences industry, as well as Pilgrim press releases and articles by experts inside and outside the company.

Blog Posts

Putting the Quality in eQMS Software
Stanley Curtis, Head of Software Engineering for SmartSolve EQMS, IQVIAYou rely on an enterprise Quality Management System (eQMS) to manage the quality of your products. Have you stopped to think about the quality of your eQMS? Do you know the level of diligence that your solution provider puts into the quality of the software that powers your eQMS? This is a guideline of what to look for when evaluating an eQMS vendor (or any software solution provider).
The Future of QMS
Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA companyQuality Management has traditionally been an area of manufacturing that was slow to adapt and change to technology shifts in the market. Over the past few years, enterprise Quality Management Software (QMS) systems have stepped up their game and caught up to the market by bringing functionality such as 3rd-party secure access, advanced analytics, and proactive monitoring to their portfolio stacks.
Pharmaceutical Organizations: Managing the Unexpected!
Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA companyUnforeseen, unanticipated, unpredicted, unplanned, unexpected. These words are typically undesirable descriptors of actions or events. Among Pharmaceutical quality and compliance professionals, they elicit downright fear because the occurrence of an unexpected event signals that something in their organization’s processes or procedures is not completely under control, and detrimental impact to patient safety is likely. For this highly regulated industry, such occurrences carry regulatory implications.
The Compliance Roadmap
Mark Scallon, Senior Principal, Commercial Compliance, IQVIAAs regulatory changes continue in the EU and the U.S., life sciences companies will need to focus more on rigor and reproducibility with respect to non-clinical, pre-clinical, clinical data, and post-market data, in addition to the subsequent documentation and audit challenges.
Transform Your Approach to Compliance From Concept to Market
Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIAToday’s drug and medical device manufacturers have several common challenges. First, nearly all are being impacted by the shifting global regulatory compliance environment as they simultaneously strive to stay ahead of the competition while safely and effectively meeting the needs of patients. Additionally, compliance has typically been seen as a department, not a shared responsibility, and collectively perceived as a cost center, not a value center.
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