Tuesday, 10 September 2019Bill 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.
Tuesday, 27 August 2019IQVIA Quality Compliance
The capabilities of an enterprise Quality Management System (QMS)
have been shown to provide significant competitive advantage among Life Sciences manufacturing and service organizations. The right company for your Quality Management System will facilitate the production of superior goods and services, while also continuously supporting regulatory compliance. That’s why the QMS vendor vetting process is a critical first step toward success.
We asked a cross-section of IQVIA Quality Compliance
subject matter experts to share their perspective on the one question likely to draw the most insightful reply from a prospective vendor about how effectively that vendor will serve an organization. Consider these perspectives and think about how they might help you select a QMS vendor that will enable you to successfully attain your quality compliance goals.
Tuesday, 20 August 2019Roxane Napoli, Associate Director - Product Marketing, IQVIA Quality Compliance
Life Sciences industry regulations are evolving rapidly, and many business leaders see these regulatory changes as a threat to growth. The pressure weighs most heavily on organizational quality compliance. But it is possible to lessen the load and address growth challenges by ascending the Quality Maturity ladder.
At any given time, a company’s maturity level falls within a range that scales from development (low quality maturity) to leadership (high maturity). The higher the stage of maturity, the quicker the realization of benefits: higher product quality, improved compliance and reduction in overall cost of quality
Tuesday, 06 August 2019IQVIA Quality Compliance
As the Life Sciences industry continues to experience an unprecedented level of change in regulatory requirements and oversight on a global scale, organizations worldwide are feeling ongoing pressure to demonstrate their quality compliance.
To help organizations take stock of where they presently stand, we asked a cross-section of IQVIA Quality Compliance
subject matter experts to share their perspective on the most effective way to assess the health of a Quality Management System
. Consider these quality system assessment insights and think about how they might help you run your own organization’s quality compliance health check.
Tuesday, 30 July 2019Joshua 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.