Real World Data and Evidence: Promise of Improved Patient Outcomes

Real World Data and Evidence: Promise of Improved Patient Outcomes

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

During the 12th Annual Conference for the Business of Biotech, held at the Moffitt Cancer Center in Tampa, Florida on March 2, 2018, it was no surprise that the theme of the conference was Discovering Tomorrow’s Cancer Cures. With the keynote on Immunotherapy and the impact it’s having on the treatment of cancer, as well as discussions on Adaptive Therapies, and breakthroughs made possible by the 21st Century Cures Act, one could feel the promise of recent and near-future advancements in the fight against cancer.

With all the science-based presentations at the conference, the session titled Real World Data: Mining Gold from a Mountain of Straw drew my attention. The session focused on Real World Data (RWD) and Real World Evidence (RWE), and how to draw insights from both to improve patient outcomes.
(more…)

Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Benchmark the State of Your QMS and Take On Quality’s Next-Gen

Last week, we discussed the much-buzzed about topic of Next Generation Quality, commonly referred to as Quality 4.0. We posed the question: What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization?

To capture a snapshot of the current QMS landscape, Pilgrim Quality Solutions recently conducted a market research study of quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies on the “state of the state” of their current QMS capabilities and needs.
(more…)

Best Practices for Attaining Next Generation Quality

Best Practices for Attaining Next Generation Quality

Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company

What does a Next-Generation Quality Management System (QMS) look like for a Life Sciences organization? In a recent market research study conducted for Pilgrim Quality Solutions, quality and compliance professionals from the Top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape and their current QMS capabilities and needs.

This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
(more…)

Bridging the Gap to Quality 4.0

Bridging the Gap to Quality 4.0

Larry Ferrere, Senior Director of Business Marketing, Pilgrim Quality Solutions, an IQVIA company

It is still amazing to me the number of companies that are managing their quality and operating in SharePoint, Excel, and with paper-based SOPs and disparate systems. Thus, it shouldn’t surprise me, but it does, that so many companies do not know the level of their Quality Maturity or their Cost Of Quality. If they say they do know, they inevitably over-rate themselves as much more mature than the norm or where they truly are, and they understate their total Cost Of Quality.
(more…)

The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

The Path to EQMS: Where Are You Along the Journey to Quality Maturity?

Rick Lowrey, General Manager, Pilgrim Quality Solutions, an IQVIA company

Over the last year, we’ve seen an increased focus by companies on the need to transform their quality management system, and even how to extend quality management processes outside their four walls to connect their suppliers. Whether it be an enterprise Quality Management Solution (EQMS), a Supplier Management focus, or the desire to improve performance while reducing total cost of ownership by moving to cloud-based solutions, all of these themes leads to a final goal; you will need to use the power of an automated, integrated solution to improve and advance one’s quality.
(more…)

Global Supplier Performance and the Regulations Driving Change

Global Supplier Performance and the Regulations Driving Change

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

Innovation within the Medical Device industry, and Life Sciences in general, continues to accelerate at an impressive clip with the introduction of groundbreaking new technologies, resulting in an increasing portfolio of medical devices. At the same time, the global healthcare industry is seeing explosive growth in the demand for those products almost as quickly as they hit the market.
(more…)

Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

Supplier Participation Required: Time is Short, Supply Chains are Long, and Compliance is Required

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

In the past few years, there has been a lot of focus on how organizations manage their suppliers. The reality for most is that their supply chains are getting longer, the need to work through those supply chain is getting shorter, and the regulatory requirements with regard to supplier management are becoming more broadly encompassing.

The most critical medical device regulatory requirements – ISO 13485:2016, ISO 9001:2015, 21 CFR Part 820, and EU MDR – have increased focus on the manufacturer’s responsibility for supplier performance. For instance, in the pharmaceutical industry, 21 CFR part 211 and ICH Q10 specifically address the management of suppliers.
(more…)

Smart Quality Management: The Impact of Industry 4.0 on QMS

Smart Quality Management: The Impact of Industry 4.0 on QMS

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

Industry 4.0, also known as Smart Factory 4.0, is labeled as the fourth industrial revolution, yet many don’t understand it or how it will impact the things they do; Quality Management is no exception. The Executives in your organization, however, are most certainly monitoring this paradigm-shifting strategy. Quality professionals should be as well. Quality professionals must ensure they are part of their company’s Industry 4.0 dialogue.

As Quality professionals forge into this new era, it’s critical to have a solid understanding of the premise and aspects of Industry 4.0/Smart Factory 4.0, and its implications for production, the extended supply chain, and their Quality Management System (QMS).
(more…)

Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Automated Computer System Validation: The Key to Increasing Your Quality System’s Efficiency

Justin L. Smith, Director of Product Management, Pilgrim Quality Solutions, an IQVIA company

Within regulated environments, such as the Life Sciences community, there are a number of top-of-mind business challenges. Key among them is to increase operational efficiencies while keeping pace with an ever-evolving regulatory landscape. A daunting challenge to say the least, mainly due to the “ever-evolving” factor.

To address the challenge, companies invest in fantastic new systems and software that provide the foundation for compliance while also affording significant efficiencies over their paper or manual processes. However, too often, companies get stuck on their initial version of software due to the cumbersome impact that computer system validation has on the upgrade process.
(more…)

Prepare Yourself: Adverse Events Code Update Coming Spring 2018

Prepare Yourself: Adverse Events Code Update Coming Spring 2018

Bernard Jee, Product Manager, Pilgrim Quality Solutions, an IQVIA company

As part of the enhancement to the electronic Medical Device Reporting (eMDR) system, the U.S. Food and Drug Administration (FDA) has indicated in its initial 2017 announcement that there will be an update to the Adverse Events codes. In particular, the code sets used in eMDR fields F10 and H6 are being harmonized with the International Medical Device Regulators Forum (IMDRF) Adverse Events Reporting terminologies, a new international guideline for coding medical device adverse events.

Based on conversation with the FDA and National Institutes of Health (NIH), the update is scheduled for implementation on April 6, 2018. An initial rollout in the pre-production environment will take place prior to April 6, 2018, allowing submitters a chance to conduct testing of their submission process to determine if any changes are required to accommodate these new codes.
(more…)