April 2016 Posts

3 QMS Considerations for Combination Products

3 QMS Considerations for Combination Products

Adonna Blasko, Marketing Manager, Pilgrim Quality Solutions

Combination products bridge medical devices, pharmaceuticals, and biotech products. Each of these areas has its own respective pre and post-market regulatory requirements, making combination products all the more complex to juggle while adhering to FDA requirements and guidance. (21 CFR parts 3 and 4, 210/211, 820, and 606)

I recently attended a session presented by Frank Davis, Regulatory Director, Pharmaceuticals with RCA Associates where he covered this topic extensively for a group of SmartSolve LifeScience EQMS users and Pilgrim employees. The ideas presented below are snippets from his session.

When it comes to how to position your combination product to the FDA when seeking market approval, many things to consider are common sense. Here are 3 key QMS considerations for combination products.


Fusion 2016: Reflections of a First-Timer

Fusion 2016: Reflections of a First-Timer

Rick Lowrey, CEO, Pilgrim Quality Solutions

“The most successful customer conferences are contingent on active customer participation and Pilgrim team collaboration.”

#PilgrimFusion 2016 was my first customer event since joining Pilgrim Quality Solutions as CEO in May 2015.  I had the opportunity to meet many customers at once and learn and understand their experience with Pilgrim as their compliance and quality partner. Having spent years in software, I’ve attended my share of user conferences both as a user and as an employee of an enterprise software business, but this year was an entirely new experience. (more…)

How Change Management and Continuous Improvement Work Together

How Change Management and Continuous Improvement Work Together

Massimo Franza, Senior Director of Software Development, Pilgrim Quality Solutions

As my colleague Kevin Lee says in his blog, The Pursuit of Zero Waste: Continuous Improvement to Drive Quality:

The Pursuit of Zero Waste requires that an organization continuously improves its current products, processes, and people involved in making the perfect device, the perfect item or the perfect process to yield zero waste.

So he really talks about how continuous improvement is the key to remain successful and to keep your organization growing.

In today’s post, we’ll discuss the relationship between change management and continuous improvement. (more…)