May 2019 Posts

The Need for QMS Transformation & Structured QMS Data

The Need for QMS Transformation & Structured QMS Data

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

As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance to one of Quality.

Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System (QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
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EU MDR: T-Minus 371 Days…Are You Equipped?

EU MDR: T-Minus 371 Days…Are You Equipped?

Mark Rhys Burke, Senior Account Executive, Pilgrim Quality Solutions, an IQVIA company

Two years ago, the European Union (EU) embarked upon a three-year transition period designed to give medical device manufacturers time to comply with new regulatory requirements. The enforcement deadline for compliance with the Medical Device Regulation (EU MDR) is May 26, 2020. That deadline is looming large for everyone in the industry.

That said, I regularly speak to individuals who express trepidation about this rapidly approaching date. They simply don’t have the necessary documents and data prepared to meet the stringent new requirements – and they’re not alone. A recent survey of more than 200 regulatory and quality leaders at major medical device companies showed that 78% of those polled did not have sufficient understanding of the new regulations. (more…)

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…)