Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality ...
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Welcome to the QM Insights show sponsored by SOLABS, with your host Ericka Moore, Head of Client Success. The QM Insights podcast is designed to provide SOLABS EQMS end users with deep dive information on the software application empowering them to fully harness the functionality this automated platform has to offer. Listeners will develop a robust understanding of the QM10 product and have the ability to understand how it is best used to maximize ROI and compliance levels.
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Welcome to the ROLDORF CAFÉ Podcast! join us for a look into the mysterious world of horology, watchmaking and also into the going's on at ROLDORF+CO in Vancouver.
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Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the second in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an ed…
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Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have…
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Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the im…
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Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready …
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Episode 63: Plan your EQMS' Development with the EQMS Maturity Model
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In this episode of the QM Insights podcast, Etienne is joined by Philippe Gaudreau, CEO of SOLABS to discuss the EQMS Maturity Model proposed by SOLABS. Managing an Enterprise Quality Management Software (EQMS) is an entirely different task based on where a company stands on the EQMS Maturity Model. Learn how this tool assists quality managers in s…
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Episode 54: Risk Management Tools and Techniques with Michael Tyo
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use…
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Episode 62: Looking Back at 2023 with SOLABS' Executives
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SOLABS' executives join together to discuss their outlook for 2023. They walk listeners through their objectives at the start of the year and more. Key Takeaways 00:51 Kevin explains what his focus was at the beginning of 2023 for the engineering department. 01:44 How many phases will be necessary for the implementation process of Kamban at SOLABS?…
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Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention. Key Takeawa…
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Episode 61: Evaluating Suppliers for an EQMS Software Purchase
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In episode 61 of the QM Insights podcast, Etienne is joined by Ericka Moore, Head of Client Success at SOLABS, and Philippe Gaudreau, CEO of SOLABS. This episode is the second in a series on purchasing an EQMS. In this episode, the guests explore the evaluation of suppliers, including how to prepare for demonstrations, the importance of evaluating …
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Episode 52: Supplier Quality Management w. Mandy Gervasio
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS, and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, Mandy and Philippe discuss supplier management from establishing a relation…
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Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, f…
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Episode 60: Purchasing an EQMS: Building a Business Case
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In episode 60 of the QM Insights podcast, Etienne is joined by Ericka Moore, Head of Client Success at SOLABS, and Philippe Gaudreau, CEO of SOLABS. This episode is the first in a series on purchasing an EQMS. In this episode, they discuss the steps to building a business case, from evaluating your requirements to getting team members on board and …
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Episode 59: The Implementation of QM10 with Ericka Moore
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In this episode of the QM Insights podcast, Etienne is joined by Ericka Moore, Head of Client Success at SOLABS to discuss the implementation process of SOLABS QM10. They discuss whether implementations are done internally or outsourced, what are the key elements that make a successful implementation, and what a successful implementation means for …
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Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode! We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common chall…
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Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from est…
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Episode 58: Analytics at SOLABS with Jamie Villeneuve
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In this episode of the QM Insights podcast, Etienne is joined by Jamie Villeneuve to discuss analytics in QM10. Jamie explains Nexgen Analytics' custom report offering, what is the end goal of analytics, and what the future holds for SOLABS in this area. Key Takeaways: 00:55 Introducing Jamie and Nexgen Analytics 02:00 What has NexGen Analytics acc…
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The Roldorf Cafe E023e WindUp Interview SoLabs Watches
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Welcome to the Roldorf Cafe Tick-Talks.The Windup Watch Fair 2023 in San Francisco is an iconic event for watch lovers.This is a short series of interviews with some of the people presenting at the watch fair. In this episode I had the pleasure to interview Rick Cosgrove of SoLabs!על ידי A Watch Enthusiast Podcast
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The Roldorf Cafe E023d_WindUp Interview_ Fears Watches
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Welcome to the Roldorf Cafe Tick-Talks.The Windup Watch Fair 2023 in San Francisco is an iconic event for watch lovers.This is a short series of interviews with some of the people presenting at the watch fair. In this episode I had the pleasure to interview Nicholas Bowman-Scargill, Fears Watchesעל ידי A Watch Enthusiast Podcast
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The Roldorf Cafe E023c_ WindUp Interview_ Zodiac Watches
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Welcome to the Roldorf Cafe Tick-Talks.The Windup Watch Fair 2023 in San Francisco is an iconic event for watch lovers.This is a short series of interviews with some of the people presenting at the watch fair. In this episode I had the pleasure to interview Mike Pearson, sales director of Zodiac watches.…
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The Roldorf Cafe E023b _WindUp Interview_LACO
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Welcome to the Roldorf Cafe Tick-Talks.The Windup Watch Fair 2023 in San Francisco is an iconic event for watch lovers.This is a short series of interviews with some of the people presenting at the watch fair. In this episode I had the pleasure to interview Sabastian Maziossek, LACO 1925על ידי A Watch Enthusiast Podcast
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The Roldorf Cafe E023a_WindUp Interview_Astor&Banks
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Welcome to the Roldorf Cafe Tick-Talks.The Windup Watch Fair 2023 in San Francisco is an iconic event for watch lovers.This is a short series of interviews with some of the people presenting at the watch fair. In this episode I had the pleasure to interview Andrew Perez, founder of Astor & Banks watches.…
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Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shar…
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The Roldorf Cafe E022: We're back.. with Fortis!
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A year of working through rebuilding .. We're BACK! And we're also back with Jupp Philip of Fortis Watches to whom we're delighted to chat with about all the new happenings with this Swiss watch brand.We hope you enjoy listening as much as we enjoyed talking to Jupp. Lots of plans ahead for the future between Roldorf and Fortis and here's some of t…
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Episode 57: SOLABS - Who We Are and Where do we Come From
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In today’s episode of the QM Insights podcast, Philippe Gaudreau, CEO of SOLABS and Ericka Moore, Head of Client Success at SOLABS discuss the business highlights of SOLABS, what will be our focus moving forward, and what are the values that drive our work! Key Takeaways 02:00 Philippe highlights key achievements we have accomplished 02:58 Ericka s…
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Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Qu…
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Episode 56: What is Coming in 2023 with SOLABS' Executives
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In today’s episode of the QM Insights podcast, SOLABS’ executives are discussing their objectives for 2023 and what clients can expect from SOLABS this coming year. Key Takeaways 00:56: introducing Ericka, Head of Client Success at SOLABS 02:17: the SOLABS QM10 User Group Meeting will return in 2023! 04:17: Introducing Martine, Head of Quality Mana…
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Episode 55: Looking Back at 2022 with Philippe Gaudreau
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In today’s episode of the QM Insights podcast, Philippe Gaudreau, SOLABS’ CEO is looking back at 2022. He discusses what he is most proud of, what changes clients can expect in 2023, and what our focus will be moving forward. Key Takeaways 00:45 – What is Philippe most proud of for SOLABS in 2022? 02:30 – We completed a 3-year backend project! 04:1…
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Episode 46 - Defining Data Quality with Steve Gens
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recom…
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Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and …
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Episode 54: Scheduling Retraining for Documents in QM10
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There are multiple scenarios in which companies must schedule retraining for existing documents. In this episode of the QM Insights podcast show, Etienne and Gretchen tackle those scenarios and share common ways that retraining is scheduled in QM10 by our clients. Key Takeaways 01:02 In which scenarios do companies have to set up retraining for doc…
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Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 53: Retrieving and Approving Documents by an External Party in QM10
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This episode of the QM Insights podcast show is focused on retrieving and approving documents by external users within QM10. Gretchen details the scenarios in which you must approve documents by external companies, how to set up their accounts based on your needs, and more! Key Takeaways 01:20 In which scenarios do a company have to retrieve and ap…
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Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 52: Searching Efficiently in QM10
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In this episode of the QM Insights podcast show, Etienne and Gretchen discuss how to search efficiently in QM10. This includes custom searches, common search queries in the search bar, the recent items list, and much more! Key Takeaways 01:05 Common ways to search within QM10 03:05 What types of custom searches can be set? 05:22 Using the Treeview …
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Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021. Our guest today is Katherine Yang-Iott. She is a consultant …
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Episode 51: Using the Function Roles for Training and Onboarding Purposes
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Today's episode of the QM Insights podcast discusses the use of Function Roles for organizing and assigning training within QM10. This can be used as early as for the onboarding of new hires! Key Takeaways: 00:30 Introducing today’s topic and guest expert 01:05 What is the role of function roles with the onboarding of new users? 03:22 Can you creat…
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Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 50: Using the Document Control Process to Send Training Notifications
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Today's episode of the QM Insights podcast details the use of the Document Control Process (DCR) to send training notifications. This can be used in or out of QM10, so it can be leveraged by clients who do not use QM10's training records management capabilities as well as those that do! Key Takeaways 01:18 Gretchen explains how you can use the Docu…
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Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry …
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Episode 49: Revising and Approving Documents in QM10
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In today’s episode, we discuss the differences between the Review and Approval cycles for documents within QM10. Gretchen Dixson, a Product Specialist at SOLABS, explains multiple scenarios where companies can save time and prevent errors by setting their review cycles through QM10 instead of performing them by email or via some other means. Key Ta…
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Episode 48: Superseding and Retiring Documents in SOLABS QM10
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In today’s episode, we discuss the differences between retiring and superseding documents within QM10. Gretchen, a Product Specialist at SOLABS, covers multiple scenarios where our clients make use of either function and provides tips on how to save time with them! Key Takeaways 00 :00 Introducing today’s topic: retiring and superseding documents i…
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Episode 47: SSRS Training Reports in SOLABS QM10 Feat. Jamie Villeneuve & Gretchen Dixson
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11:43
In today’s episode, we discuss the new SSRS training reports available with QM10. Join Gretchen and Jamie as they discuss how the new reports were designed and how this will impact the lives of our customers moving forward! Key Takeaways 00:30 Introducing today’s topic and guests 01:20 What are the improvements we have made to SSRS reports? 03:24 G…
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Episode 46: Audit Capabilities in QM10 Release 10.9.0 - Included for All Our Clients!
15:11
15:11
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15:11
Listen on Youtube: https://www.youtube.com/watch?v=Lq6xkQiUIzA In today’s episode, we discuss the new audit capabilities of QM10 R. 10.9.0. Join Etienne, Gretchen, and Martine as they explore the audit process, detail how it is used internally at SOLABS, and look at the new reporting capabilities related to the audit process. 00:23 Today’s topic: n…
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The Roldorf Cafe E021: What Makes A Badass Watch
56:24
56:24
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56:24
Welcome to Episode 21 of The Roldorf Café Podcast!In this episode we've got a bottle of wine from Jules Bistro In Gastown! We're exploring some recent news:The Zenith Defy 21 : https://bit.ly/T_TDefy21Felipe Pantone: https://www.felipepantone.com/The Christopher Ward C60: https://bit.ly/ChrisWc60We talking Tech - The Calasis Oscillator: https://bit…
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Episode 45: Online Assessment in QM10 Release 10.9.0
13:37
13:37
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13:37
The QM Insights podcast show is back on its mission to help SOLABS’ clients to learn from experience. In today’s episode, we are looking at the new online assessment capabilities that are made available for all our clients starting with the next release of QM10. Key Takeaways 00:40 Introducing today’s guests: Gretchen, Martine, Mathieu & Philippe 0…
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Episode 44: Document Management in QM10, Part 3: Document Administration
15:36
15:36
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15:36
The QM Insights podcast show is back on its mission to help SOLABS’ clients to learn from experience. Today’s episode is Part 3 of our series on how QM10 helps our clients with document management. In this episode, we focus on the tools available to Document Administrators to assist with their document administration needs. 00:41 Introducing today’…
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Episode 43: Document Management in QM10, Part 2: Periodic Reviews When No Changes Are Required
14:26
14:26
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14:26
In today’s episode, the team discusses how QM10 can help our clients manage Periodic Review Cycles for their documents that require it. This episode focuses on scenarios where the periodic review identifies that no changes are required to the document. This is part 2 of a series on how SOLABS QM can help manage your Document Periodic Reviews. Etien…
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Episode 42: Document Management in QM10, Part 1: Periodic Reviews With the Document Control Process
10:58
10:58
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10:58
The QM Insights podcast show is back on its mission to help SOLABS’ clients Learn from Experience. In today’s episode, the team discusses how the QM10 Document Control Process can help our clients manage Periodic Review Cycles for their documents that require it. This is part 1 of a series on managing document Periodic Reviews using QM10. Etienne L…
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Episode 41: SOLABS Services, Security and Architecture
17:13
17:13
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17:13
The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience. In today’s episode, the team discusses the services offered by SOLABS, how we handle security and our responsibility in regard to data and reporting. Etienne Langlois, SOLABS’ Marketing Coordinator is taking over as today’s host while Ericka is taking…
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Episode 40: SOLABS' New Tagline, Our Q1 Performance and The Importance of System Ownership w. Philippe Gaudreau
16:21
16:21
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16:21
The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience. In today’s episode, the team discusses SOLABS’ performance over Q1 2021, how we got to the Learn From Experience tagline and the importance of System Ownership procedures. Etienne Langlois, SOLABS’ Marketing Coordinator is taking over as today’s host …
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