The QT9 Q-Cast

QT9 Software

The QT9 Q-Cast explains what’s happening in quality—clearly and without the hard-to-learn jargon. We cover the standards that matter, what’s new, what’s changing next, and how different industries are affected. Each episode turns real examples into simple step-by-step takeaways you can use right away across QMS, ERP and MRP. You’ll hear from quality leaders, operators, and regulatory pros who make complex ideas easy to understand—and even a little fun. Updated bimonthly, so you can expect a new episode every other week. Powered by QT9 Software.

Episodes

  1. 6 DAYS AGO

    #11: FDA QMSR Readiness: Training, Risk, and Audit Evidence That Holds Up

    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 active. The discussion moves beyond theory and into inspection reality—how FDA investigators will follow risk threads across complaints, CAPA, management review, and design controls rather than auditing procedures in isolation. Michelle explains why QMSR is not a documentation rewrite exercise, why ISO 13485 certification alone does not equal compliance, and how leadership decision-making under risk becomes central to inspection outcomes. The episode explores the retirement of QSIT, the shift toward faster, data-driven inspections, and why siloed spreadsheets and disconnected systems will create exposure. The core message is clear: QMSR rewards organizations with integrated, validated systems, executive accountability, and real-time visibility across quality processes—while exposing fragmented workflows and performative compliance. For quality leaders, regulatory professionals, and executives in medical devices and life sciences, this episode outlines what “inspection-ready” truly means under QMSR enforcement.

    25 min

  2. 6 DAYS AGO

    #10: FDA QMSR Compliance Calls for a New Mindset | FDA 21 CFR Part 820 Evolution

    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 it is not. This conversation focuses on the why behind the regulation, the FDA’s intent, and how inspections move away fromclause-by-clause audits toward risk-driven system evaluation. Michelle explains why QMSR is not a simple renumbering exercise, why ISO 13485 certification alone is not enough, and how FDA-retained requirements like complaints, CAPA, MDR, traceability, and labeling remain central enforcement drivers. The episode also explores which manufacturers willfeel the transition most, where legacy QSR assumptions break down, and whyrisk-based thinking is now embedded across the entire quality system—not justdesign controls. The key takeaway from Part 1 is clear: QMSR rewards organizations with connected systems, leadership accountability, and real risk ownership—whileexposing fragmented processes and compliance theater. If you’re responsible for quality, regulatory, or executive oversight in medical devices or life sciences, this episode sets the foundation for understanding how FDA inspections change under QMSR before diving intoimplementation details.

    25 min

  3. 27 JAN

    #9: Why Change Management Fails - And How Quality Leaders Can Get It Right

    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 people-centered realities of change management—from passive resistance and middle management alignment to training, governance, and measurable behavior change.For organizations implementing or optimizing a QMS, ERP, or operational excellence initiative, this episode offers practical insights to help ensure change translates into sustained performance improvement. Key points:• Why resistance to change is often emotional, not rational• How underestimating effort derails QMS and operational initiatives• The critical role of middle management in sustaining change• Using pilots, data, and structured problem-solving to drive adoption• Measuring real behavior change beyond quality “platitudes”Learn how QT9’s integrated, cloud-based QMS and ERP platform supports structured change, user adoption, and continuous improvement. Visit QT9 Software to see how connected quality and manufacturing systems help teams move from intention to execution.Tags & hashtags:Change management, QMS implementation, operational excellence, quality management systems, continuous improvement, manufacturing leadership, regulated manufacturing, process improvement, ERP and QMS integration#QT9Software #ChangeManagement #QMS #OperationalExcellence #ManufacturingLeadership #ContinuousImprovement #QualityManagement

    25 min

  4. 13 JAN

    #8: Quality Management Made Paperless

    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 discussion explores the evolution from paper and spreadsheets to fully integrated QMS platforms, highlighting how connected quality data helps organizations shift from reactive firefighting to proactive, preventive quality management. For manufacturers facing growing regulatory pressure, this conversation outlines a clear path to improving visibility, traceability, and ROI through an integrated, cloud-based approach .Key points:The hidden costs and compliance risks of paper-based quality systemsHow fragmented “islands of software” slow audits and decision-makingThe three levels of QMS maturity and why integration mattersUsing quality data to reduce the cost of poor quality and protect reputationShifting quality from a cost center to a competitive advantageLearn how QT9’s integrated, cloud-based QMS helps manufacturers streamline compliance, improve visibility, and turn quality into a growth driver by visiting QT9Software.com to see how an integrated system can support your organization.Tags & hashtags:QT9 Software, QMS, EQMS, quality management system, paper to digital, audit readiness, compliance management, ISO 9001, ISO 13485, IATF 16949, medical device manufacturing, automotive manufacturing, regulated industries, cost of quality, integrated QMS, cloud QMS#QT9Software #QMS #EQMS #QualityManagement #ManufacturingCompliance #AuditReadiness #PaperlessQMS #RegulatedIndustries

    23 min

  5. 9 JAN

    #7: Software Validation: A Practical Guide

    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 QT9’s developer-level validation supports life sciences and medical device companies, why risk assessments are essential, and how cloud-based QMS software can significantly reduce validation burden while keeping you compliant and audit-ready.Watch now to understand validation the right way—and see how QT9 QMS helps you stay compliant, confident, and inspection-ready. Learn more at QT9 Software.#QT9 #QMS #FDACompliance #ISO13485 #SoftwareValidation #LifeSciences #MedicalDevices #QualityManagement #RegulatoryCompliance

    24 min

  6. 16/12/2025

    #6: High Cost of Low Quality: QMS in Cannabis

    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 of quality in operational excellence, and the impact of regulatory compliance on cannabis companies.To Reach out to Samantha, you can find her at PureAnalytics.net or email her at info@pureanalytics.net#cannabis, #qualitymanagement, #ISO #standards, #operational #excellence, #regulatory #compliance

    25 min

  7. 02/12/2025

    #5: ISO 9001:2026 Updates Explained: What Quality Leaders Must Know

    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 from official committee updates, DIS ballot timing, and industry guidance, Lorraine clarifies what’s likely changing, what’s staying steady, and how quality teams across manufacturing, life sciences, medical devices, aerospace, and automotive can get ahead of the curve. From climate-change requirements already in effect to expected emphasis on digitalization, ethical behavior, and leadership accountability, this episode offers a grounded roadmap for operational excellence.Listeners will learn why the 2026 revision is an evolution, not an overhaul — and why most core clauses (4–10) remain stable. Lorraine also demystifies widespread myths, including the misconception that AI and eQMS tools will become mandatory. Instead, companies should focus on strengthening leadership, documenting climate-change considerations, piloting digital tools early, and preparing for a three-year transition window post-publication.Whether you’re maintaining ISO 9001:2015 compliance or preparing for the upcoming FDIS in 2026, this episode equips quality professionals with high-confidence, transcript-accurate insights aligned with QT9’s mission: helping organizations digitize, automate, and elevate their quality systems with clarity and confidence.Get in touch with Lorraine Caputo through Lumanity at www.Lumanity.com

    22 min

  8. 18/11/2025

    #4: QT9 Business Intelligence 3.0: From Data to Decisions with ERP + QMS

    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 build custom dashboards, KPI visualizations, and live reports without manual exports, VLOOKUPs, or spreadsheet maintenance. Riley walks through new features like combined QMS/ERP reporting, automated data refresh schedules, editable dashboard templates, pre-built analytics, training delinquency reporting, inventory aging dashboards, and the all-new SQL Query Builder for advanced data queries.  Whether you're a quality manager, operations leader, plant manager, or data-driven manufacturer, this episode shows how QT9 BI helps teams eliminate data silos and make faster, more accurate decisions.

    24 min

  9. 05/11/2025

    #3: Navigating CMMC: Self Assessment to Certification

    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: Christian Reyes, QT9. Chapters 00:00 Why your PO is gated by SPRS + CMMC’s purpose01:06 Meet guest Rhia Dancel (NSF, C3PAO)01:42 Why CMMC replaced self‑attestation; 320 objectives03:03 Verified assessments vs. self‑assessments03:21 Levels 1–3 overview (FCI vs. CUI; NIST 800‑171/172)04:14 CMMC as both security framework and contract gate05:01 Who needs CMMC? Prime → sub flow‑down06:03 32 CFR program rule; 48 CFR clauses; rollout through Nov202807:04 FCI vs. CUI (plain‑English examples)08:30 COTS scope discussion09:10 Do SaaS vendors need CMMC? (depends on CUI & flow‑down)10:18 Scoping Level 2: SSP, network diagram, asset inventory10:54 C3PAO vs. consultant; mock assessments11:21 What counts as evidence; why technical proof wins12:09 Level 3 path (after Level 2 with C3PAO → DoD/DIBCAC)12:49 FedRAMP Moderate / equivalent for cloud CUI13:19 First 5 tasks to start (gap analysis → remediation → docs)14:36 Minimum viable evidence (SSP + network + inventory)15:21 When software vendors should pursue CMMC; scheduling realities17:26 Level 1 as a trust signal; annual affirmation18:40 How primes view vendors without CMMC in SPRS19:23 Level 2 timeline; enclaves; control inheritance22:16 Where to find NSF (Cyber AB Marketplace) & wrap‑up DisclaimerThis episode shares general information—not legal advice. Always verifyrequirements in your specific solicitations and contracts. If this helped, please like 👍,subscribe 🔔, and share with ateammate who owns security, contracts, or compliance. Hashtags#CMMC #NIST800171 #NIST800172 #CUI #SPRS #FedRAMP #DefenseIndustrialBase #DIB#C3PAO #QT9QCast #NSF

    23 min

  10. 21/10/2025

    #2: AS9100 to IA9100: The 2026 Shift

    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 guidance on the anticipated Q4 2026 publication window and transition period, what auditors will emphasize (e.g., ethical behavior evidence, MSA), rising cybersecurity/IT security “shall” expectations, practical product safety clarifications (Clause 8.1.3), and smart ways to time your transition audit to upgrade from AS9100 to IA9100 without gaps. Mike also shares where small teams should start (think: a simple gauge R&R first) and busts common myths like “we need to rewrite our whole QMS” or “FAI alone proves process capability.” Reach out to Mike Varney Quality Management Solutions: MVarneyQMS.comYou can also find Mike Varney on LinkedIn: https://www.linkedin.com/company/mike-varney-quality-management-solutions-llc/Check out www.QT9Software.com to learn more about us!

    24 min

  11. 07/10/2025

    #1: From Startup to QMS Leader

    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 software and building a company that now serves over 1,000 customers globally. Discover how he pivoted QT9 during the 2008-2009 financial crisis by focusing on customer feedback and developing new modules for the aerospace and medical device industries. Learn about QT9's unique, customer-centric approach, which includes a one-flat-price model and a commitment to culture, even as the company has grown and evolved. Brant discusses his mindset of continuous creation and the "startup energy" that drives the company's explosive growth and product innovation. This episode is a must-listen for anyone interested in quality management systems, business growth, and the power of a strong company culture. Tune in to hear the story behind one of the top competitors in the QMS world, and how a focus on quality and customer satisfaction can lead to long-term success. Check out www.QT9Software.com to learn more about us!

    19 min
  • 11 Episodes

About

The QT9 Q-Cast explains what’s happening in quality—clearly and without the hard-to-learn jargon. We cover the standards that matter, what’s new, what’s changing next, and how different industries are affected. Each episode turns real examples into simple step-by-step takeaways you can use right away across QMS, ERP and MRP. You’ll hear from quality leaders, operators, and regulatory pros who make complex ideas easy to understand—and even a little fun. Updated bimonthly, so you can expect a new episode every other week. Powered by QT9 Software.

Information

  • Creator
    QT9 Software
  • Years Active
    2025 - 2026
  • Episodes
    11
  • Rating
    Clean
  • Copyright
    © QT9 Software
  • Show Website
    The QT9 Q-Cast