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…)

Deviation Management: Taking GMP Compliance to the Next Level

Deviation Management: Taking GMP Compliance to the Next Level

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

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

It happens that many of these answers lie within your existing deviation management processes and data. The key to addressing these increasingly common issues is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly. (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…)

The Future of Pharmaceuticals

The Future of Pharmaceuticals

IQVIA

It is an exciting, and formidable, mandate – to solve the world’s healthcare challenges. To continually find new ways of delivering value and real outcomes to patients, providers, and payers. To rise to the challenge to be more precise, from clinical trials to commercialization. To make the most out of increasingly limited resources. And to minimize while maximizing success. That is what IQVIA, the Human Data Science Company, is about.

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The Compliance Roadmap

The Compliance Roadmap

Mark 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. (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…)

Supplier Risk and its Impact on Corporate Risk

Supplier Risk and its Impact on Corporate Risk

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

Risk continues to be a major focus in most businesses today, regardless of industry. In the past few years, Life Sciences organizations have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. Subsequently, the standards organizations and regulators around the globe have taken note and responded accordingly. So it’s no surprise that minimizing business and operational risks, as well as legal and regulatory compliance, is on every executive’s mind, and for good reason.

Supplier risk, put simply, is the probability associated with a supplier causing an interruption in an organization’s supply chain by impacting the availability of products and services within that supply chain. Supplier impact, at a minimum, effects two legs of the three-legged Governance, Risk, and Compliance (GRC) stool: those two legs are Risk and Compliance. The impact of suppliers on an enterprise can be significant. (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…)