Quality Posts

Putting the Quality in eQMS Software

Putting the Quality in eQMS Software

Stanley Curtis, Head of Software Engineering for SmartSolve EQMS, IQVIA

You 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). (more…)

The Future of QMS

The Future of QMS

Joshua Centner, Industry Solutions Group Manager, Pilgrim Quality Solutions, an IQVIA company

Quality 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. (more…)

Pharmaceutical Organizations: Managing the Unexpected!

Pharmaceutical Organizations: Managing the Unexpected!

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions, an IQVIA company

Unforeseen, 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. (more…)

Transform Your Approach to Compliance From Concept to Market

Transform Your Approach to Compliance From Concept to Market

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

Today’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. (more…)

Quality within the BioPharma Industry Landscape

Quality within the BioPharma Industry Landscape

Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions, an IQVIA company

The American Society for Quality, touted as the “Global Voice of Quality,” states that manufacturers in the pharmaceutical industry are always working to balance the demands of meeting global regulations and production costs, in an effort to produce the most innovative research and development while also producing safe, reliable prescription drugs. As a biopharmaceutical industry veteran, I know the challenge is real. In fact, when illustrating a graphic representation of the Biopharma industry’s information management landscape, as I see it, the depiction is quite dense and complex. (more…)

Continuing Education in the Quality Space

Continuing Education in the Quality Space

Lynn Willis, Partner Enablement and Training Manager, Pilgrim Quality Solutions, an IQVIA company

An important facet of any organization’s quality efforts is the knowledge of its personnel. The depth of each employee’s knowledge and skills contributes to the company’s ability to achieve its mission and goals. Conversely, employees who do not have the knowledge to perform their day-to-day functions pose a quality risk. This equation applies as much to long-time employees as to new hires. (more…)

19 Quality Compliance Resolutions for 2019

19 Quality Compliance Resolutions for 2019

Be the change you want to see in 2019. We asked members of the Pilgrim blogging community to tap into their subject matter expertise to compile a list of some behaviors or routines that have been proven to fuel success. Consider these 19 suggested resolutions for Quality and Compliance practices, and think about how you can turn them into daily habits to drive your organization’s continuous improvement this year and beyond. (more…)

Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a wonderful holiday season and a prosperous 2019.
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MedTech Company of the Year 2018 Finalists

MedTech Company of the Year 2018 Finalists

MDDI Staff, MD+DI Magazine

Medical Device and Diagnostics Industry (MD+DI) Magazine announced it’s 2018 list of finalists for MedTech Company of the Year. The industry publication named Boston Scientific among the list of 10 companies that have “risen above the rest in 2018.” For over a decade, both IQVIA and Pilgrim Quality Solutions, an IQVIA company, have enjoyed a long-standing relationship with industry leading Boston Scientific. MD+DI cited Boston Scientific’s aggressive Mergers & Acquisition strategy. In July, the company’s CEO Mike Mahoney “reassured investors that the firm’s M&A appetite was part of a very well laid out plan.” (more…)

Fusion 2018: Pilgrim Quality, IQVIA, and Next-Generation Quality

Fusion 2018: Pilgrim Quality, IQVIA, and Next-Generation Quality

Dan Jacob, Research Director, LNS Research

Pilgrim Quality Solutions last month hosted an enjoyable, inspiring, and valuable global customer conference, Fusion 2018, in Tampa, Florida. This year’s conference provided an opportunity for attendees to learn about Pilgrim’s strategy to drive the Next-Generation Quality vision, and to share the exciting benefits that Pilgrim, now as part of IQVIA Technologies, can provide to its customers. (more…)