The QT9 Q-Cast

When regulatory requirements change, many organizations rush into unnecessary QMS updates, creating confusion, inconsistency, and audit risk. In this episode of the QT9 Q-Cast, Christian Reyes sits down with Phil Guarino, VP of Quality at SCIE Solutions, to discuss how quality leaders can take a controlled, risk-based approach to regulatory and standards changes. Drawing from decades of experience...

Spreadsheets are often the starting point for quality management, but as organizations grow, they can become a hidden source of risk, inefficiency, and compliance challenges. In this episode of QT9 QCast, we explore the four biggest hidden costs of spreadsheet-based quality systems and why regulated manufacturers are moving toward connected, audit-ready quality management software. Learn how disco...

Rework looks productive — people are busy, parts are moving, the line is running. But underneath, margin is leaking and your quality system is absorbing chaos. Christian Reyes breaks down the three failures behind the “rework tax” and a 30-day plan to bring it under control.

What if your quality problem is not under-inspection, but over-inspection? In this episode of Compliance Lab on The QT9 Q-Cast, Christian Reyes tackles the over-inspection bottleneck: the moment when added checks, reviews, and approvals stop acting like safeguards and start acting like a traffic jam for your QMS. The episode shows how teams often respond to a complaint, deviation, failed audit, or...

Open CAPAs are not just a quality problem. They are cash burn in disguise. In this episode of The QT9 Q-Cast: Compliance Lab, we break down how a growing Corrective Action and Preventive Action (CAPA) backlog creates audit risk, slows operations, and extends the Cost of Poor Quality (COPQ) across regulated manufacturing. If your CAPA system lives in spreadsheets, if ownership is fuzzy, or if closi...

Quality management has undergone a dramatic transformation—from paper-based systems and scattered spreadsheets to integrated, cloud-based platforms that drive efficiency, compliance, and visibility. In this conversation, veteran auditor Brian Powers shares insights from nearly 30 years in the field, exploring how quality systems have evolved and where they’re headed next. Discover how modern QMS,...

In this episode of The QT9 Q-CAST, host Christian Reyes sits down with James Schloz, Lead Trainer and Implementer at QT9, to break down how QT9 approaches QMS implementation and training for customers across regulated industries. James walks through QT9’s customer-centric implementation model, explaining the five key phases used to successfully deploy QT9 QMS—from project planning and data setup t...

As of February 2, 2026, the FDA has officially begun enforcing the Quality Management System Regulation (QMSR)—a structural shift aligning 21 CFR Part 820 with ISO 13485 and redefining how medical device manufacturers will be inspected. In this QT9 Q-Cast episode, host Christian Reyes speaks with Michelle Keane, QA/RA Director at ComplyGuru, to unpack what enforcement looks like now that QMSR is a...

As of February 2, 2026, the FDA has officially begun enforcing the Quality Management System Regulation (QMSR)—a structural shift that aligns 21 CFR Part 820 with ISO 13485 and changes how medical device manufacturers willbe inspected. In Part 1 of this QT9 Q-Cast episode , host Christian Reyes isjoined by Michelle Keane, QA/RA Director at ComplyGuru, to break down what QMSR actually is—and what i...

Change is inevitable—but successful change is not. In this Q-CAST episode, QT9 Software sits down with Matt Kroll, President of Chalmers Street Consulting, to explore why change initiatives stall and how organizations can drive real adoption across quality and operations. Drawing from real-world examples in manufacturing, distribution, and regulated industries, this conversation breaks down the pe...

In this Q-CAST episode, QT9’s Director of Operations for EMEA, Angela O’Sullivan, shares real-world insight from decades in regulated industries on why paper-based quality systems create hidden risk and cost. Drawing on experience across automotive and medical devices, Angela explains how manual and fragmented systems impact compliance, audit readiness, and overall business performance. The discus...

What happens when an FDA investigator asks for your validation evidence—are you ready, or scrambling? In this episode, QT9 Vice President Max Austin breaks down FDA and ISO 13485 software validation requirements in plain language. From risk-based validation to common misconceptions and real-world inspection scenarios, this conversation demystifies what “fit for intended use” truly means. Learn how...

In this episode of The QT9 Q-Cast, host Christian Reyes discusses quality management in the cannabis industry with Samantha Miller, a pioneering cannabis scientist and entrepreneur. They explore the importance of quality management systems (QMS) in cannabis, the challenges of implementing these systems, and the benefits they bring to businesses. Samantha shares insights on ISO standards, the role...

ISO 9001 is being updated for the first time in over a decade — and the 2026 revision is shaping up to be the most significant modernization since 2015. In this episode of the QT9 Q-Cast, host Christian Reyes sits down with veteran ISO consultant Lorraine Caputo of Lumanity to separate credible signals from speculation and break down what organizations can confidently prepare for today. Drawing fr...

Unlock the power of unified manufacturing data with the new QT9 Business Intelligence (BI) Tool, launching December 2025. In this episode of the QT9 Q-Cast, host Christian Reyes sits down with data analyst Riley Wise to explore how QT9 BI 3.0 brings together QT9 QMS, QT9 ERP, Excel, REST APIs, MySQL, and other external data sources—all in one centralized BI platform.  Learn how manufacturers can b...

Is your prime saying they can’t award the PO until your CMMCstatus shows in SPRS ? In this QT9 Q‑Cast episode, host Christian Reyes interviews Rhea Dancel (Senior Manager of Information Security at NSF , a C3PAO ) to demystify CMMC compliance —who needs it, how Levels 1–3 map to NIST SP 800‑171/172 , and exactly what assessors expect. Guest : Rhea Dancel , NSF (C3PAO &certification body). Host...

AS9100 is set to become IA9100 in 2026—and aerospace suppliers are already asking what that means for timelines, audits, and their QMS. In this episode, host Christian Reyes (QT9 Software; Lead Auditor for ISO 13485) interviews Mike Varney, aerospace quality consultant and president of MVQMS Consulting, to break down what’s likely coming and how to get ahead of it. Expect plain-English, early guid...

Welcome to the inaugural episode of the QT9 Q-Cast, the show that simplifies quality management for business leaders and professionals. In this episode, host Christian Reyes sits down with Brant Engelhart, founder and CEO of QT9 Software, a market leader with over 20 years in the industry. Brant shares his journey from a "de facto quality manager" for a small manufacturer to creating a QMS softwar...