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

Press Releases

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Pilgrim in the News

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Blog Posts

Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency
Justin L. Smith, Director of Product Management, Pilgrim Quality SolutionsWithin regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor. To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
The Supplier Qualification Framework – Assessment, Responsibility, and Control
Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality SolutionsLast week, I had the opportunity to explore the Life Sciences Supplier Qualification and Control Framework along with Nicky Dodsworth of Premier Research, Dr. Benjamin del Tito of the Biologics Consulting Group, Peggy J. Barry of Synergy Consulting, and The Knowledge Group. In today’s post, we’ll review key takeaways from Pilgrim’s portion of the webinar. If you’d like to view the entire webinar, you can watch the on-demand version of Life Sciences Supplier and Contractor Qualification and Control Framework Explored here.
EU Medical Device Regulations: Changes on the Horizon
Cynthia Lambert, Regulatory and Industry Specialist, Pilgrim Quality SolutionsThere are significant changes on the regulatory horizon in Europe due to the publication of the new European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which were approved by the European Parliament on April 5, 2017. The industry is now subject to a three-year transition period for compliance among medical devices, and a five-year period for compliance among in vitro diagnostic (IVD) products.
The Case for Cloud: Why Regulated Industries Should Pay Attention!
Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality SolutionsCloud computing can be loosely defined as the process by which a set of data resources are housed somewhere remote and are accessed using the Internet. Traditionally, these resources have been housed inside the data owner’s own office building behind a firewall, providing very limited or no access from the outside, and thereby, protecting these resources from outside intrusion. But the pendulum is swinging again. Forty years ago it was in the form of time-share computing. Today, in the global marketplace, an increasing number of organizations are opting to move to the Cloud – which in many respects is today’s time-share computing environment, only faster, cheaper, highly secure, reliable, and more accessible.
Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance
Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality SolutionsLast week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
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