“Moving to an electronic system is not going to fix a process problem.” – Ashley Hehr

In this PRN Quality Assurance Podcast episode, host Chris Milawski joins Jeanette Stewart and QA expert Ashley Hehr to break down the reality of moving your operations to electronic systems. While technology offers incredible efficiency, a system will not automatically create quality—your workflows do. They dive deep into the essential prerequisites that must be established before you digitize a process, from defining role stop-gaps to understanding back-end functionality and system validation.

This podcast is brought to you by PRN Pharmaceutical Research Network, a clinical CRO focusing on ophthalmology.

[FREE RESOURCE]
Unsure if your systems are truly inspection-ready?
Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card. Download here: https://prnorb.com/slide-deck-download/

Other episodes here: https://www.youtube.com/playlist?list... or on other major podcast streaming platforms.  
 
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To learn more about PRN, our services, and for any questions you might have:   
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“Monitors are the eyes and ears of the sponsor.” – Ashley Hehr

In this PRN Quality Assurance Podcast episode, host Chris Milawski joins Jeanette Stewart and QA expert Ashley Hehr to discuss clinical research monitoring and how QA supports and guides monitors as the sponsor’s “eyes and ears” at study sites. They focus on common pitfalls in monitoring reports (trip reports) and emphasize the content and strategies for writing trip reports.

This podcast is brought to you by PRN Pharmaceutical Research Network. A clinical CRO focusing on ophthalmology.

[FREE RESOURCE]
Unsure if your systems are truly inspection-ready?
Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

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Other episodes here: https://www.youtube.com/playlist?list... or on other major podcast streaming platforms.

[CONNECT WITH US]
To learn more about PRN, our services, and for any questions you might have:
Visit PRN: www.prnorb.com
Follow Us on LinkedIn: https://www.linkedin.com/company/prn-....

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Regulators know people make mistakes. And if they walk in the door and they see uber clean source, they will start digging because they know that there's no way anybody could have this good of source." – Chris Milawski

When mistakes happen in clinical research, the temptation to sweep them under the rug or use temporary shortcuts like sticky notes can be incredibly high. But from a regulatory standpoint, "uber-clean" source documentation with zero errors is a massive red flag. Agencies expect human error—what they actually look for is the documented proof of how you handled and corrected those mistakes.

How do you transition from a culture of finger-pointing to a robust, compliant CAPA system that regulators love to see?

Welcome to the fifth episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, PRN’s CEO and Co-Founder Jeanette Stewart, and QA expert Ashley Hehr as they dive into Episode 5, Mistakes Happen: How to Appropriately Document and Follow Up.

Brought to you by PRN Pharmaceutical Research Network. A clinical CRO focusing on ophthalmology.

[FREE RESOURCE]

Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

[CONNECT WITH US]
To learn more about PRN, our services, and for any questions you might have:

Visit PRN: www.prnorb.com
Follow Us on LinkedIn: https://www.linkedin.com/company/prn-pharm...

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"Probably one of the biggest things you run into is the plain simple fact that some sponsors have a set it and forget it attitude about their vendors.” – Chris Milawski

Many sponsors fall into the "set it and forget it" trap—assuming that because they’ve hired a top-tier vendor, they can step back entirely. But from a regulatory standpoint, the buck stops with the sponsor. How do you maintain "trust but verify" oversight without micromanaging your partners out of their expertise? 

Welcome to the fourth episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, PRN’S CEO and Co-Founder Jeanette Stewart, and QA expert Ashley Hehr as they dive into Episode 4, Partners, Processes, Proof: Smarter Vendor Oversight.
Brought to you by PRN Pharmaceutical Research Network. A clinical CRO focusing on ophthalmology.

[FREE RESOURCE]
Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

[CONNECT WITH US]
To learn more about PRN, our services, and for any questions you might have:
Visit PRN: www.prnorb.com
Follow Us on LinkedIn: https://www.linkedin.com/company/prn-pharm...

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"If you want a cake to turn out the same every time, you need to follow a recipe. An SOP is a recipe." – Jeanette Stewart.

But how do you ensure your procedures provide tangible evidence of compliance without causing a disaster waiting to happen?

Welcome to the third episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, PRN’S CEO and Co-Founder Jeanette Stewart, and QA expert Ashley Hehr as they dive into Episode 3, Policies with Purpose: SOPs That Prove Performance.

Brought to you by PRN Pharmaceutical Research Network, a clinical CRO focusing on ophthalmology.

[FREE RESOURCE]
Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

[CONNECT WITH US]
To learn more about PRN, our services, and for any questions you might have:
Visit PRN: www.prnorb.com
Follow Us on LinkedIn: https://www.linkedin.com/company/prn-pharm...

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"Knowledge is power. When you know something, you understand something and you can communicate it back to somebody else, that is very powerful." – Ashley.
But how do you ensure your team actually retains that knowledge without just checking a box?

Welcome to the second episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris, Jeanette Stewart (CEO of PRN), and QA expert Ashley Hehr as they dive into Episode 2, Training That Translates: Practical Preparation for GxP Performance.

Brought to you by PRN Pharmaceutical Research Network, LLC. A clinical CRO focusing on ophthalmology.

[FREE RESOURCE]
Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

[CONNECT WITH US]
To learn more about PRN, our services, and for any questions you might have:
Visit PRN: www.prnorb.com
Follow Us on LinkedIn: https://www.linkedin.com/company/prn-pharm...

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"Quality is everybody's responsibility" – Ashley Hehr.

But how will you implement it without "busting the budget"?

Welcome to the first episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, Jeanette Stewart (CEO of PRN), and QA Specialist Ashley Hare as they introduce a new series called THE QUALITY ASSURANCE PODCAST dedicated to helping clinical research professionals navigate the world of quality assurance in Ophthalmology. Brought to you by PRN, a best-in-class CRO celebrating 26 years of ophthalmic experience in clinical research.

[FREE RESOURCE]

Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card.

Download here: https://prnorb.com/slide-deck-download/

[CONNECT WITH US]

To learn more about PRN, our services, and for any questions you might have:

Visit PRN: www.prnorb.com

Follow Us on LinkedIn: https://www.linkedin.com/company/prn-pharm...

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