Compliance Posts

Simplifying Today’s Regulatory and Compliance Complexities

Simplifying Today’s Regulatory and Compliance Complexities

Bill Buzzeo, General Manager, U.S. Center of Compliance Excellence, IQVIA

The quality, regulatory, safety, and commercial compliance management areas are quite often looked at as organizational necessities rather than value-added functions. They also are areas that sometimes lack innovation and transformation.

In a recent global survey of pharmaceutical CEOs, regulatory concerns continue to be viewed as a threat to growth. In fact, since 2013, these concerns, collectively, are among the top three threats as reported by pharma executives (PWC’s 20th Annual Global Pharma CEO Survey). (more…)

Be Aware! Security Training and Employee Engagement

Be Aware! Security Training and Employee Engagement

Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions, an IQVIA company

As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of employee security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

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

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions: 25 Years of Quality, Compliance, and Success

Pilgrim Quality Solutions, an IQVIA company

This week, Pilgrim Quality Solutions proudly celebrates 25 years of commitment to helping hundreds of organizations around the globe manage product quality with confidence, enhance patient safety, and be more prepared for audits than ever before. Pilgrim has pioneered quality management software solutions since 1993, bringing industry best practices to the Life Sciences sector, and partnering with the world’s leading companies to enhance their quality processes, positively impact their financial performance, and achieve regulatory success.

In honor of this accomplishment, we look back over the last 25 years of events that have defined Pilgrim as the leading provider of enterprise quality and compliance management software and services for the Life Sciences and other highly regulated industries.
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Pick Up a New Habit: Making Quality a Priority

Pick Up a New Habit: Making Quality a Priority

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions, an IQVIA company

“Quality isn’t an act, it’s a habit.”

Aristotle said it first. But it doesn’t take a philosopher or a scientist to recognize that excellence doesn’t happen overnight. Just ask the drum major in the local high school band or the prima ballerina in the regional ballet company. It takes ongoing commitment to reach the pinnacle and continuous approaches to quality improvement to remain there.

The QA director at a leading pharma or medical device company know this, too. Very well. The practice of continual improvement starts with a unified, enterprise-wide commitment to ongoing best efforts and to process improvement. (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.
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Combination Products: Past, Present, and Future – Part 3 of a Series

Combination Products: Past, Present, and Future – Part 3 of a Series

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

In the first two parts of this series, Combination Products: Past, Present and Future, we reviewed the historical path of combination products and the complex road to regulatory and quality compliance for this product category, leading up to today’s current state. It is important to recall that Combination Products is its own product category, independent of Medical Device, Drug, and Biologics. We discussed that fact that combination products have their own cGMP (21 CFR Part 4), but the cGMPs of the constituent parts (i.e. devices, drugs, and/or biologics) must not be neglected either.
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2018 Resolutions: Make Quality & Compliance Collective Top Priorities

2018 Resolutions: Make Quality & Compliance Collective Top Priorities

Do you ever wonder how many individuals truly commit to their New Year resolutions? How many actually follow through? The figure is difficult to calculate because more often than not, there is no system of checks and balances, no accountability for individuals’ behavior. In 2018, consider not only your own personal Quality and Compliance goals and resolutions, but engage your colleagues in sharing them with you. Be one another’s support network and ensure that those intentions are realized. Make the behaviors that support them a part of your organization’s Quality Culture for 2018.
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Happy Holidays from the Pilgrim Quality Blog Team

Happy Holidays from the Pilgrim Quality Blog Team

It has been our pleasure this year to share with you our perspectives on the latest topics in quality, compliance, and risk management. We wish you a delightful happy holiday season and a prosperous 2018.
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Not-So-Standard SOPs: What You Need to Know

Not-So-Standard SOPs: What You Need to Know

Davor Milosevic, Quality Assurance Manager, Pilgrim Quality Solutions, an IQVIA company

Formal written Standard Operating Procedures (SOPs) are required both by the Food & Drug Administration (FDA) and European Medicines Agency (EMA). While the term standard suggests “business as usual,” there’s definitely nothing standard about what they represent. SOPs, in part, demonstrate compliance and say to inspectors that you know what you are doing and why.

However, for the last couple of years, SOP deficiencies have been one of the top findings in FDA audits on both the drug and device manufacturing sides. In fact, almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs, or lack of compliance in following them, within an organization. As such, the entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects or mismanagement of the related processes.
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