Episode 7 – DIGITAL BY DESIGN: Driving Compliance Without the Chaos | The QA Podcast | PRN

“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/ Timestamps: 00:00 – 02:35 Intro: The Myth of the Electronic "Cure-All" 02:35 – 03:54 Why Systems Don't Create Quality (Processes Do!) 03:54 – 05:14. Step 1: Define Processes 05:14 – 05:55 Step 2: Define Roles 05:55 – 08:17 Step 3: Fix a Defined Problem 08:17 – 17:20 Step 4: Define Systems: Intended Use, Configuration, and Expected Outputs 17:20 – 18:03 Mid Break 18:03 – 20:17 Step 5: Validation/Effectiveness Checks 20:17 – 23:34 Closing thoughts: Connect with PRN for Quality Assurance Other episodes here:    • The Quality Assurance Podcast   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:   / prn-pharm...       -----    Creative Commons — Attribution 3.0 Unported — CC BY 3.0   Music promoted by Copyright Free Music - Background Music For Videos   👉  @podcastbackgroundmusic