Tuesday, 14 May 2019Stanley 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).
Tuesday, 07 May 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.
Tuesday, 23 April 2019Kari 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.
Tuesday, 02 April 2019Mark Scallon, Senior Principal, Commercial Compliance, IQVIA
As 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.
Tuesday, 26 March 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.