Podcasts about solabs

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Best podcasts about solabs

Latest podcast episodes about solabs

SOLABS QM Insights
Episode 64: SOLABS' Roadmap with Philippe Gaudreau

SOLABS QM Insights

Play Episode Listen Later Nov 26, 2024 17:02


In this episode of the QM Insights podcast, Etienne and Philippe discuss the latest updates to QM10 and what's in the pipeline for the upcoming months!   View SOLABS' full roadmap here: Roadmap for SOLABS QM10, QM APPs and Services – SOLABS Knowledge Base   Key takeaways: 00:20 SOLABS news 03:20 Introducing some new features recently made available to clients 07:15 Our work on the reporting portal 11:00 We're revamping QM10's UI! 14:20 A variation of the deviation QM APP is in the works for smaller companies   Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 59: Introduction to Investigations with Michael Tyo

Automating Quality

Play Episode Listen Later Oct 1, 2024 18:31


Automating Quality Episode 59 – Inspection Readiness with Michael Tyo   Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today's episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly.   Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting.   Key Takeaways 00:42 Introducing today's guest: Michael Tyo 01:42 Today's subject is the investigations, from why they exist to how they must be performed 02:22 Why are we doing investigations? 04:21 What may trigger an investigation? 08:04 What must be investigated? 10:00 Who is responsible for doing investigations? 14:41 What are the tasks once the investigation is launched?     Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 63: Plan your EQMS' Development with the EQMS Maturity Model

SOLABS QM Insights

Play Episode Listen Later Apr 2, 2024 13:03


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 structuring the continuous improvement of their quality system.   Key Takeaways 00:45 Why are we working on an EQMS Maturity Model? 02:24 What is the benefit of this tool for Life Sciences companies? 04:50 Philippe explains how the maturity model can adapt to companies with different business perspectives. 06:30 Do we have recommendations for companies looking to structure their continuous improvement timeline? 08:48 Who will manage and operate the EQMS Maturity Model within a company? 10:45 Etienne highlights how this tool will help inter-departmental cooperation with quality operations. 12:13 We will present a poster on this topic at the 40th SQA annual quality college starting April 7th through 11th.   Contact us at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 62: Looking Back at 2023 with SOLABS' Executives

SOLABS QM Insights

Play Episode Listen Later Jan 19, 2024 14:47


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? 03:38 Ericka explains why the Client Success department's main area of focus in 2023 was customer satisfaction. 04:58 The return of the User Group Meeting was a great success! 06:19 Martine, head of Product Quality Management presents her areas of focus in 2023. 08:10 Etienne shares his experience while obtaining our ISO certification. 08:55 Philippe, CEO of SOLABS explains what his areas of focus were at the beginning of 2023. 12:13 Etienne shares what he is most proud of for 2023.

SOLABS QM Insights
Episode 61: Evaluating Suppliers for an EQMS Software Purchase

SOLABS QM Insights

Play Episode Listen Later Dec 5, 2023 14:51


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 the implementation practice as well as the solution and when is the right moment to discuss money.   Key Takeaways 01:20 What is the next step after formalizing your requirements? 03:30 Presenting vendors with your initial scope helps to receive a tailor-made demonstration. 04:43 How do you evaluate implementation practices for the new software? 07:36 When is the right time to discuss budget and money? 09:43 How do you go about checking references in today's market?

Automating Quality
Episode 52: Supplier Quality Management w. Mandy Gervasio

Automating Quality

Play Episode Listen Later Nov 28, 2023 17:28


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 relationship with new suppliers to maintaining this relationship and keeping the trust between your two organizations alive.   Key Takeaways: 01:30 Mandy discusses her current role and how it is linked to supplier management 03:40 Being able to work with partners that allow you to operate as one team in a seamless way is an incredible success factor 04:37 Mandy points red flags when entering a relationship with a supplier 07:15 Communicating only when there are problems to manage is a risky behavior 09:03 From a GCP perspective, how can you establish a good relationship with CROs and other suppliers? 13:26 How do you maintain your relationship with those suppliers and keep the trust alive and active?

Automating Quality
Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Automating Quality

Play Episode Listen Later Oct 17, 2023 20:30


Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. 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, from management accountability to the importance of managing data integrity.   Key Takeaways 02:06: What are the key conferences Mandy attended this year? 04:49: The importance of keeping management accountable for quality objectives. 06:24: Accountability now revolves around individual responsibilities. 10:21: Data integrity is a recurring theme in discussions. 14:30: Training on data integrity has evolved in recent years. 16:07: Supplier Management is another important topic.   Contact us at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 60: Purchasing an EQMS: Building a Business Case

SOLABS QM Insights

Play Episode Listen Later Oct 2, 2023 16:20


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 working around objections.   Key Takeaways 01:15: How does a company start the process of evaluating an EQMS purchase? 04:25: The importance of making sure the timing is right for your company. 05:23: How big does your company need to be before implementing an EQMS? 08:10: How do you define your user requirements? 11:24: What are the allies you need internally and how do you get them on board with your project? 13:42: What are the common objections you have to be prepared for?   For any questions or feedback, contact us at solabs-podcast@solabs.com.

SOLABS QM Insights
Episode 59: The Implementation of QM10 with Ericka Moore

SOLABS QM Insights

Play Episode Listen Later Aug 15, 2023 14:30


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 SOLABS.   Key Takeaways 00:49 Why do we perform all of our implementations internally? 02:38 Is there an overlapping between implementation and the Client Success roles? 05:41 What is the expected duration of an implementation project at SOLABS and why? 08:30: Who is involved in the implementation from the client's perspective? 09:22 Read more on implementation on our Knowledge Base at docs.solabs.com 10:00 Key tips that make a successful implementation Contact Ericka at emoore@solabs.com Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Automating Quality

Play Episode Listen Later Aug 1, 2023 16:06


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 challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more!   Key Takeaways 01:01 Introducing today's return guest: Jamie Villeneuve from NexGen Analytics 02:35 What are some of the common challenges in GMP companies from an analytics standpoint? 05:01 What departments need input from analytics? 07:31 How has analytics evolved over time for GMP companies? 10:11 New nomenclature and approach for analytics 11:38 Why do companies invest more and more in analytics? 13:03 The top 5 metrics GMP shopfloor analytics companies need to track 14:42 Thank you to Jamie for joining us for this special episode #50! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

Automating Quality

Play Episode Listen Later Jul 4, 2023 16:07


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 establishing the organization's goals to providing the right information to the right people at the right time.   Key Takeaways 01:58 Introducing today's guest: Jamie Villeneuve from NexGen Analytics 03:19 Who needs information from analytics in an organization? 05:36 How do you know what information is relevant to report on? 08:52 How do you communicate analytics effectively to all staff at a company? 11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company's needs? 15:12 Thank you to Jamie for joining us!   Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 58: Analytics at SOLABS with Jamie Villeneuve

SOLABS QM Insights

Play Episode Listen Later May 16, 2023 15:48


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 accomplished for SOLABS' clients so far? 03:00 What is the custom report offering for our clients? 06:40 What is the end goal for analytics? 10:15 Do analytics have to adapt to a company's reality over time? 12:32 What does the future hold for SOLABS in terms of analytics?

Automating Quality
Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

Automating Quality

Play Episode Listen Later May 2, 2023 14:18


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 shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more!   Key Takeaways 00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX 02:53 Who are the main parties involved in the medical devices supply chain? 04:15 What is the process to getting a new supplier on board? 07:56 Are all audits in the future going to be remote? 10:04 Do suppliers change their processes to make themselves easier to audit? 12:55 Thanks to Joseph and our listeners for this great episode!

SOLABS QM Insights
Episode 57: SOLABS - Who We Are and Where do we Come From

SOLABS QM Insights

Play Episode Listen Later Apr 18, 2023 14:16


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 shares some of the highlights she is most proud of at SOLABS 06:23 How is Supplier Quality Control going to be a priority for SOLABS moving forward? 11:10 We are working on supporting suppliers on both ends – whether you are auditing your suppliers or being audited yourself 11:30 Philippe presents SOLABS' company values

Automating Quality
Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia

Automating Quality

Play Episode Listen Later Apr 4, 2023 19:02


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 Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and  Computer Software Assurance (CSA), and more!   Key Takeaways 02:17 Introducing today's guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix 03:33 What is the Case for Quality? 05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought 07:44 What is the first thing you should focus on when implementing a quality system? 10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices 12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management 17:38 Thanking Joseph and our listeners for today's episode! Contact Joseph at jsilvia@orielstat.com or on LinkedIn Oriel STAT A MATRIX: www.orielstat.com Reach out to us at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 56: What is Coming in 2023 with SOLABS' Executives

SOLABS QM Insights

Play Episode Listen Later Mar 7, 2023 14:13


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 Management at SOLABS 05:00: SOLABS is ISO 9001:2015 certified! 06:47 Introducing Kevin, Head of Engineering 08:11 We are working towards automated testing 10:22 Philippe talks about SOLABS' focus in 2023: client satisfaction! 12:38 We are working on controlled copies this year 13:32 Thank you to all our listeners!

SOLABS QM Insights
Episode 55: Looking Back at 2022 with Philippe Gaudreau

SOLABS QM Insights

Play Episode Listen Later Feb 21, 2023 14:55


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! 04:19 – How will the backend projects impact our clients? 06:00 - About the Client Success Assistance offering 11:00 – Where does the Learn From Experience tagline come from?   Reach out to us at solabs-podcast@solabs.com

Fifth Wrist Radio
Independent Thinking - Sō Labs is back! Rick and Andrew (@solabs.co) return to talk about the new Layer 2 Series (new movement & colours)

Fifth Wrist Radio

Play Episode Listen Later Jan 9, 2023 108:06


Another episode of the Independent Thinking Show for @FifthWrist Radio. This is a place dedicate to showcasing the great people doing interesting and cool things in the world of horology. Hosts: Roman (@TimesRomanAU) and Adam (@mediumwatch) speak with returning guests Rick and Andrew from @solabs.co about their latest watch release Sō Labs Layer 2 Series. Join us for a conversation about how the Sō Labs Layer 2 has evolved from the previous series, now available in an automatic movement, new colours and a new cool colour wheel date/date feature. We also talk modern design classics; cool clocks; evolution of Sō Labs brand and design identify: and challenges in designing and bringing cool indie watches to market. If you like indie watches - you will like this episode. Special reminder that Sō Labs is available for a special price during January 2023!!! Shout-outs in this episode: Ochs und Junior (@ochsundjunior); Charlie Dunne (@strictlyvintagewatches); Alain Silberstein (@alainsilbersteinofficial); Christopher Ward (@christopherwardlondon) and @veblenist Recommendations from this episode: Rick - @PolKurucz, @teenage.grandpa Andrew - @waitlisted Adam - @clockwheels, @rosneathian Roman - @watchbruh Also, make sure you check out Andrew's other watch brand project: Astor & Banks (@astorandbanks) Theme Music: The Wrong Time by Silent Partner (via YouTube Free Music Channel) Follow us on Instagram: @FifthWrist  To join our crew group chat then please email us at contact@fifthwrist.com and if you have time please leave us a review wherever you listen to our podcast. We hope you enjoy listening to this episode as much as we enjoyed making it! Stay On Time

SOLABS QM Insights
Episode 54: Scheduling Retraining for Documents in QM10

SOLABS QM Insights

Play Episode Listen Later Nov 8, 2022 11:07


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 documents? 02:26 How do some of our clients handle retraining on SOPs? 03:39 What about periodic classroom training? 05:54 For-cause retraining such as in the event of a deviation requiring an update to an SOP 09:05 If you're unsure about how QM10 could be used to handle a situation, please reach out to our team and we can put you on the right track   Contact us at solabs-podcast@solabs.com

SOLABS QM Insights
Episode 53: Retrieving and Approving Documents by an External Party in QM10

SOLABS QM Insights

Play Episode Listen Later Oct 11, 2022 10:57


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 approve documents by an external company? 04:00 Are there scenarios in which companies do not create external accounts for their suppliers? 05:53 Best practices on the use of external users VS full accounts for contractors and consultants 10:00 Reach out to our team if you need assistance!   Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin

Automating Quality

Play Episode Listen Later Oct 4, 2022 20:44


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. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.   Today's topic of discussion is artificial intelligence and machine learning. Ben delivers some background on those buzzwords, how they relate to the FDA's action plan, how this will impact the medical device industry moving forward, and more!   Key Takeaways 01:22 Introducing today's guest Ben Locwin 03:26 Some background on artificial intelligence and machine learning 05:24 Common misunderstandings about those buzzwords 07:10 What is deep learning versus machine learning and AI? 08:43 How do these areas relate to the FDA's action plan? 14:05 How will this impact the medical device industry moving forward? 18:40 Mandy thanks Ben for joining us on the show

SOLABS QM Insights
Episode 52: Searching Efficiently in QM10

SOLABS QM Insights

Play Episode Listen Later Sep 13, 2022 12:37


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 for search purposes 06:54 Using common search queries in the search bar 09:12 Can we restrict external users from searching? 11:48 Thanks to Gretchen and to our listeners   Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott

Automating Quality

Play Episode Listen Later Sep 6, 2022 25:46


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 and analyst for Gens and Associates and the study lead for the firm's first Quality-focused benchmark. She's had 2 decades of experience as a scientist and researcher. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.   Key Takeaways 01:32 Introducing today's guest: Katherine Yang-Iott, an Analyst at Gens & Associates 03:07 Katherine introduces Gens & Associates and the context of this study 06:07 What were the key findings of this survey? 08:50 What is a QMS in the perspective of Katherine 11:12 What was the goal of the study in terms of information produced? 14:20 How the pandemic has increased companies' focus on supplier management 20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today 21:20 Philippe shares his thoughts on the benchmark's key learnings 22:57 What are the next steps for G&A in the world of quality? 25:15 Mandy thanks our guest and invites listeners to share their feedback

SOLABS QM Insights
Episode 51: Using the Function Roles for Training and Onboarding Purposes

SOLABS QM Insights

Play Episode Listen Later Aug 9, 2022 13:40


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 create different “onboarding” function roles for different job profiles? 05:58 How should users handle function roles that are no longer in use? 8:50 You must individually assign the training activities to users even if you have assigned them to their function roles 10:00 Why you should not always assign all the training in a user's roles at once 12:20 Closing thoughts & thanking our listeners   Contact us at solabs-podcast@solabs.com

Automating Quality
Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

Automating Quality

Play Episode Listen Later Aug 2, 2022 18:22


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. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA.   The topic of today's discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one.   Key Takeaways 00:17 Mandy introduces Ben back to the show 01:13 Today's topic is the Real-World Evidence framework 02:24 What is the FDA's definition of Real-World Evidence? 06:50 What is being looked at for the framework? 09:16 What are the 4 Vs of data? 11:18 How do you define your hypotheses in advance when looking at data? 15:44 Mandy reflects on today's discussion

SOLABS QM Insights
Episode 50: Using the Document Control Process to Send Training Notifications

SOLABS QM Insights

Play Episode Listen Later Jul 19, 2022 10:29


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 Document Control Process (DCR) to send notifications for training 02:29 At which step will you handle training? 05:13 Checking the "no training is required" box allows you to explain that training is completed in another system 06:19 What if you have some documents that you don't need training on at all? 08:20 Gretchen shares her final thoughts on the topic

Automating Quality
Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin

Automating Quality

Play Episode Listen Later Jul 12, 2022 22:01


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 for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today's discussion is about defining what are Real-World Data and Real-World Evidence (RWD & RWE).   Key Takeaways 01:13 Introducing today's guest: Ben Locwin 03:03 Philippe discusses the link between Real-World Data and its connection with technology 05:05 Ben defines Real-World Data and Real-World Evidence 10:28 Philippe discusses the importance of the integrity of data gathered from different sources 12:18 The importance of looking at the data with a specific hypothesis in mind 15:45 There is a lack of standardizing in data that leaves some concern 17:07 What is the FDA looking for regarding Real-World Data and Real-World evidence? 20:00 Ben shares his closing thoughts on the topic   Contact us at solabs-podcast@solabs.com

SOLABS QM Insights
Revising and Approving Documents in QM10

SOLABS QM Insights

Play Episode Listen Later May 31, 2022 10:17


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 Takeaways 00:30 Today's topic is the Review and Approval cycles 01:35 What's the difference between a Review and an Approval cycle? 02:30 Are the users in the Review cycle the same people that are going to be approving afterward? 04:00 This is much better than sending reviews by email 05:10 Do all our clients use the Review cycle and why? 08:21 Additional advice from Gretchen regarding those cycles. 09:20 Thanks to Gretchen and our listeners!

SOLABS QM Insights
Superseding and Retiring Documents in SOLABS QM10

SOLABS QM Insights

Play Episode Listen Later Apr 21, 2022 11:05


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 in QM10 01:17 What are the differences between retiring and superseding 02:22 Do traces of retired documents still exist within the software? 03:40 Can you bring a document back if it ever becomes relevant again? 05:36 How often do our users use superseding instead of retiring documents? 07:32 What happens to training related to a document when you supersede it? 09:15 A couple tips for our users. 10:18 Thank you to our listeners!

SOLABS QM Insights
SSRS Training Reports in SOLABS QM10 Feat. Jamie Villeneuve & Gretchen Dixson

SOLABS QM Insights

Play Episode Listen Later Mar 8, 2022 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 Gretchen explains how this will impact the user experience 04:41 There is a new parameter to exclude training activities that are not due yet from your reports 06:25 Looking at multiple departments in a single report is a possibility moving forward 07:51 It is possible to sort all users that do not belong to a department, which can be especially useful for external users 08:59 We are sure those new upgrades will improve compliance and give better visibility of the training status 10:15 Thank you to our guests and listeners!

SOLABS QM Insights
Audit Capabilities in QM10 Release 10.9.0 - Included for All Our Clients!

SOLABS QM Insights

Play Episode Listen Later Feb 2, 2022 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: new audit management capabilities made available for our clients 00:40 Introducing today's guests: Gretchen Dixson & Martine Boire 01:36 Why did we include the audit process for all our clients moving forward? 03:41 The workflow steps of the audit process. 04:31: What information can be entered in each step? 06:11 Preparing for the audit step 07:13 Following up on the audit 08:28 How we use this process internally at SOLABS 10:51 Closing the audit process 12:00 Talking about the new reports for audit 14:10 Thank you to our guests and listeners! #solabs #qm10 #qminsights #podcast #qualitymamagement #audit

Fifth Wrist Radio
Independent Thinking - Thank You and Happy New Year!

Fifth Wrist Radio

Play Episode Listen Later Dec 31, 2021 23:58


This is the last episode of the Independent Thinking Show for @FifthWrist Radio for 2021. Don't worry - we will be back in Jan 2022! 2021 has certainly been a challenging year for many reasons (COVID lockdowns, travel restrictions, black panther and tiffany dials everywhere, etc). I just wanted to take a quick pause and say a HUGE thank you to all Fifth Wrist Radio crew, contributors, reviewers, guests, cohosts and (especially) listeners.  Thank you for staying with us!  Love you all (even the Rolex wearers  :-) HAPPY NEW YEAR!  See you in 2022! Roman (@TimesRomanAU)  A special thank you to all the 2021 Independent Thinking podcast guests listed below (in order of episode release). You all have inspired me and made me better!  Christian Lass (@Christian_Lass), with a special shout-out to the amazing Hannelore @gravalance) Roger Smith (@rogerwsmithltd) Reuben Schoots (@reubenschotts) Chris Manning (@Silver_Hand) Tony from @Rescapement Todd Levin (@levinartgroup1) Roland G Murphy (@rgmwatches) Tommy Jobson (@tommy.jobson) Theo Diehl (@richardmille) Rick and Andrew from @Solabs.co Comrade Gary @Shteyngart Allen Farmelo of @Beyond.The.Dial Nicholas Bowman Scargill of @FearsWatches Nich and Josh Hacko of @nicholashackowatch Roland Iten and Carol (@rolanditen) Magnus Bosse of @MING Watches Rebecca and Craig Struthers (@strutherswatchemakers) James Lamb (@jameslambwatches) John Reardon (@collectabilityllc) - Official Wristie-Award-winning "2nd best watch podcast in the world" :-) Peter Doble (@doblehpeter) And Charlie Dunne @books_on_time and Ricardo from @mywatchmemoir  Festive messages from Adam @mediumwatch, Benoit @petitesecondes and Bob @brownvillewatchguy. Bonus AUDIO Track: IT's 2021 Theme Music: Tick Tock by Jimmy Fontanez / Media Right Productions (via YouTube Free Audio Library) Follow us on Instagram: @FifthWrist. To join our crew group chat then please email us at contact@fifthwrist.com and if you have time please leave us a review wherever you listen to our podcast.

SOLABS QM Insights
Online Assessment in QM10 Release 10.9.0

SOLABS QM Insights

Play Episode Listen Later Nov 2, 2021 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 01:15 Find additional resources in our User Guides Index 01:49 What are the new features coming with QM10 release 10.9.0? 04:30 Our ongoing relationship with Questionmark 05:40 Demonstration of an employee performing an online assessment 08:18 The role of support in the implementation of the 10.9.0 release 10:44 Learn more about our validation package in our eRoom 13:00 Thank you to our guests and listeners   Find our User Guide Index here: User Guides Index – SOLABS Contact us at solabs-podcast@solabs.com #solabs #qm10 #qualitymanagement

SOLABS QM Insights
Document Management in QM10, Part 3: Document Administration

SOLABS QM Insights

Play Episode Listen Later Sep 21, 2021 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's guests: Gretchen Dixson and Philippe Gaudreau 01:04 Find previous episodes from this series here: QM Insights Podcast – SOLABS 01:35 Philippe provides a sneak peek of our 10.9 release 04:50 Our support team is currently scheduling the upgrades to the latest version of QM10. 05:34 Gretchen details the tools available for document administrators – Document Types, Document Workflow Templates and PDF Rendering Templates ??       Document Types help you create default “electronic templates” for your various documents 07:01 Document Workflow Templates can be used to easily assign document review/approval tasks if they are often assigned to the same person 07:48 What are the options in terms of default settings for Document Types? 08:51 You can set date fields to allow entry of past dates or only current/future dates depending on your needs 10:28 Clients usually set default folder locations to ensure that their documents are automatically placed in the correct Treeview folder location 12:51 We like to help our clients with initial configuration and ongoing review. Learn more about our Client Success Agreements here: Client Success Assistance - Service Level Agreement – SOLABS 14 :37 Etienne thanks today's guests & listeners   Find our User Guide Index here: User Guides Index – SOLABS Contact us at solabs-podcast@solabs.com #solabs #qm10 #qualitymanagement

SOLABS QM Insights
How can SOLABS QM Help with Periodic Reviews, Part 2: No Change Required

SOLABS QM Insights

Play Episode Listen Later Jul 8, 2021 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.   Etienne Langlois, Sr. Marketing Coordinator, is today's host. Our guests are Gretchen Dixson, Head Trainer and Product Specialist at SOLABS, and Philippe Gaudreau, CEO at SOLABS.   Listen to Part 1 Here   00:26 Today's topic is document Periodic Reviews where it is identified that no changes are required. 01:14 Find more documentation on today's topic here 01:37 What is a Periodic Review where no changes are required? 02:21 How should you handle a "no change" scenario? 03:52 Why Document Coordinators play a critical role in handling those scenarios. 05:02 How do some of our clients enter the Reason for Change when there is no change? 06:04 Changing the meaning of signature align with your needs for Periodic Reviews. 07:12 How to handle training in "no change" scenarios. 08:03 What if you do not want to trigger retraining? 10:20 Learn how to use the document control process for Periodic Reviews here 11:27 QM10 is flexible to meet your needs - Gretchen stresses the importance of establishing your procedures within your SOPs to ensure consistency. 13:16 Thanks to our listeners! Cosmetic Change option when Revising Documents Document Periodic Review Cycle

Fifth Wrist Radio
Independent Thinking - a dash of colour and fun with @solabs.co

Fifth Wrist Radio

Play Episode Listen Later Jun 20, 2021 90:44


Another episode of the Independent Thinking Show for FifthWrist Radio. This is a place dedicate to showcasing the great people doing interesting and cool things in the world of horology. Hosts: Roman (@TimesRomanAU) and Adam (@mediumwatch) Guests: Rick and Andrew (@solabs.co) In this episode, we chat with two cool dudes about the funky casual watch brand they started (So-Labs).So-Labs watches are quartz, colourful, fun and have a unique way to display time (all the things you CAN'T say about your average Rolex). Join us for a conversation about bringing a new watch brand to market, good design, Josef Albers, colour theory, Chicago watch scene and the importance of connecting with your customers, and not being afraid to create watches with a unique perspective. We also talk modern design classics, and just where to look in your own house to find the best foam insert for watch packaging - the answer will surprise you. Adam and Rick delve deeply into why plastic is such an important modern material, discuss nostalgia for the 1980s and 90's; express disgust at Yeezy sneakers; and explore Rick's favourite plastic objects, clocks and toys. If you like watches and a bit of fun - you will like this episode. Shout-outs in this episode to friends of Fifth Wrist Radio podcast: Lewis Heath (@anordain), Roland G Murphy (@rgmwatches), Ochs und Junior (@ochsundjunior), Colibrica Design (@colibrica_design) and Habring (@habring2). Recommendations from this episode Adam: @sisyphus_industries Rick: @barbie_roadkill, @brucebakerbonsai, @6inchwrist, @neontalk and @retrogeist Andrew: @TimesRomanAU and @mediumwatch (both excellent picks!) Roman: @justcassette, @teenage.grandpa Follow So-Labs on Instagram @solabs.co and their website www.so-labs.co Also, make sure you check out Andrew's other watch brand project: Astor & Banks. New Theme Music for 2021: Circle Round by Spinning Clocks (via YouTube Free Music Channel) Follow us on Instagram: @FifthWrist and FifthWrist.com

SOLABS QM Insights
How Can QM10 Help With Periodic Reviews, Part 1

SOLABS QM Insights

Play Episode Listen Later Jun 8, 2021 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 Langlois, Sr. Marketing Coordinator, is today's host. Our guests are Gretchen Dixson, Head Trainer, and Product Specialist at SOLABS, and Philippe Gaudreau, CEO at SOLABS.   00:44 Introducing today's guests, Gretchen Dixson and Philippe Gaudreau 01:09 Learn more on today's topic by visiting our Knowledge Base 02:07 What are Periodic Reviews and why are they important? 02:50 How can Periodic Reviews be handled within QM10? 04:40 Some of our clients use the Document Control Process in creative ways! 06:04 Tips for setting up your Periodic Review process in QM10 08:36 Training can be tied to Periodic Reviews depending on your needs 09:57 Thanks for listening! User Guides Index – SOLABS SOLABS QM10: Document Periodic Review Cycles – SOLABS #solabs #qm10 #qualitymanagementsystems

SOLABS QM Insights
SOLABS Services, Security and Architecture

SOLABS QM Insights

Play Episode Listen Later May 18, 2021 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 a break for health reasons. Our guests today are Kevin Byrne Langlois, Head of Engineering at SOLABS and Philippe Gaudreau, CEO at SOLABS.   00 :32 Introducing Today’s Guests, Kevin Byrne Langlois and Philippe Gaudreau 01:08 You can learn more about today’s topic on our Knowledge Base at docs.solabs.com 01:52 The different types of services we offer at SOLABS 04:23 Kevin details the Core Services and Enhancement Services our clients use frequently 08:26 Our responsibilities towards data, reporting and analytics 12:24 Is SOLABS’ hardware redundant and who is responsible for making sure it runs smoothly? 16:24 Etienne thanks the guests and listeners 16:45 Reach us at solabs-podcast@solabs.com for suggestions   Reach out to us at solabs-podcast@solabs.com Visit SOLABS’ Knowledge Base at SOLABS

SOLABS QM Insights
SOLABS' New Tagline, Our Q1 Performance and The Importance of System Ownership w. Philippe Gaudreau

SOLABS QM Insights

Play Episode Listen Later Apr 20, 2021 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 while Ericka is taking a break for health reasons. Philippe Gaudreau, SOLABS’ CEO, is our guest today!   0:36 Etienne introduces today’s guest: Philippe Gaudreau 1:14 SOLABS’ performance in Q1 2021 4:13 New resources in SOLABS’ Knowledge Base 5:50 Etienne explains the reasoning behind SOLABS’ new tagline: Learn From Experience 6:36 Philippe discusses how QM10 allows our clients to learn from experience 10:25 What is System Ownership and why is it critical in today’s world? 14:14 We recommend having System Ownership procedures for QM10 and any other softwares you use 14:56 Thanks to our clients for listening and our best wishes! 15:47 How to contact us

SOLABS QM Insights
Product Roadmap, New Reporting Capabilities and More With Philippe Gaudreau, Jamie Villeneuve & Gretchen Dixson

SOLABS QM Insights

Play Episode Listen Later Mar 16, 2021 27:29


The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. In today's episode, the team discusses our product roadmap for the upcoming months and years, introduces our partners at Nexgen and the exciting reporting capabilities they bring to our clients and more! Today’s guests are Philippe Gaudreau, SOLABS’ CEO, Jamie Villeneuve, Owner of NexGen Analytics and Gretchen Dixson, Product Specialist at SOLABS.   0:40 - Ericka introduces today’s guests: Gretchen, Jamie & Philippe 1:13 - Philippe discusses our approach for QM10’s roadmap and why we made these choices. 3:10 – What are the next items on SOLABS’ roadmap? 6:29 – Will we still be working on bug fixes and performance enhancement systematically for each release? 8:28 – Ericka introduces SOLABS’ partnership with NexGen Analytics and our new reporting offering. 9:35 - How did this collaboration come to life? 11:20 – Jamie shares his background working with the life sciences industry while leveraging his love for data. 13:30 – Jamie details what he has done for SOLABS’ clients so far. 16:38 – Where do we want to take this partnership in the future? 18:30 – Jamie speaks French! 18:50 – What are SOLABS’ Client Success Assistance Services? 20:05 – Gretchen explains the three main areas in which she helps clients as part of our Client Success Assistance Services. 23:55 – Ericka shares a few new resources that are available on SOLABS’ Knowledge Base. 26:00 – Ericka thanks our guests and reflects on today’s episode.   Learn more about our new reporting capabilities at emoore@solabs.com Visit SOLABS’ Knowledge Base at SOLABS

SOLABS QM Insights
QMI 38 – SOLABS 2020 in Numbers & Our New Software Support Specialist! With Philippe, Kevin and Mathieu

SOLABS QM Insights

Play Episode Listen Later Feb 2, 2021 22:02


The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. In this week’s episode, our host Ericka Moore is joined by SOLABS’ CEO Philippe Gaudreau, our Head of Engineering Kevin Byrne Langlois and our new Software Support Specialist Mathieu Carriere! The team discusses how much QM10 was used throughout 2020, the reasoning behind hiring a Software Support Specialist, its expected impact for our clients, how Mathieu’s profile fits such a role and more!   Key Takeaways: 0:30 – Ericka announces today’s topic: the latest news from SOLABS as a company 0:50 – Philippe discusses SOLABS’ performance over the last year 1:55 – How many documents have been made effective through QM10 in 2020? 4:05 – Philippe discusses which process apps are the most used across our clients 6:24 – Ericka recaps how SOLABS’ usage has increased in 2020 8:05 – Kevin announces the arrival of a new member in the support team 8:40 – What is the reasoning behind hiring someone with a highly technical background in a support role? 10:32 – Kevin details the role of a Software Support Specialist and the expected impact for our clients 12:24 – Is it true that Kevin had to prove to the rest of the team that that this job actually existed? 13:07 – Mathieu shares his professional background prior to joining SOLABS 15:22 – How does Mathieu’s background prepare him for his new role at SOLABS? 16:10 – Mathieu explains why he chose SOLABS as his next challenge 17:43 – What are Mathieu’s interests outside of work? 19:16 – Ericka reflects on today’s episode 19:56 – Ericka names a couple new resources in SOLABS’ Knowledge Base   Contact solabs-podcast@solabs.com to chat with our team!

SOLABS QM Insights
Looking Back at 2020 With SOLABS’ Executives

SOLABS QM Insights

Play Episode Listen Later Dec 15, 2020 40:16


The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week’s episode is a little different from usual as our host Ericka Moore is joined by SOLABS’ executives to look back at the challenges, realizations and overall performance of each department for 2020. These executives are SOLABS’ CEO Philippe Gaudreau, our Head of Engineering Kevin Byrne Langlois, our Head of Product and Quality Management Martine Boire and finally our Marketing Coordinator Etienne Langlois. Key Takeaways 0:45 – Today’s topic is looking back at 2020 with SOLABS’ executives 1:00 – Ericka introduces today’s guests: Philippe Gaudreau, Kevin Byrne Langlois, Martine Boire and Etienne Langlois 2:05 – Philippe discusses his software tech inspirations for 2020 4:25 – The team discusses the most challenging projects that they’ve tackled this year 9:13 – Philippe shares his thoughts on the adaptability and productivity of the SOLABS’ team in the face of COVID-19 12:16 – The team shares the realizations they are most proud of for 2020  17:50 – Etienne explains how he measures the performance of the marketing department and what the results have been this year 21:50 – Ericka shares her metrics and the performance of the client success department 24:57 – Martine discusses the same information for the product and quality management department 28:45 – Kevin details the performance of the engineering department for 2020  37:00- Ericka thanks the guests and expresses her best wishes for 2021 38:32 – Philippe shares his final words for our clients this year

SOLABS QM Insights
Best Practices Around Document Control with Philippe, Martine, Gretchen and Etienne

SOLABS QM Insights

Play Episode Listen Later Nov 10, 2020 24:34


The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week on the show, Ericka Moore returns as your host! She is joined by SOLABS’ CEO Philippe Gaudreau, SOLABS’ Head of Product and Quality Management Martine Boire, SOLABS’ Product Specialist and Head Trainer Gretchen Dixson and finally SOLABS’ Marketing Coordinator Étienne Langlois. In today’s episode, the team discusses best practices around document control, both in and out of QM10. They discuss key points to consider when implementing a document control process, the importance of training document coordinators, how to effectively organize your documents and much more! Key Takeaways 0:46 –    Ericka introduces today’s guests, Philippe, Martine, Gretchen and Étienne 1:11 –    An overview of the chat function available on solabs.com 2:55 –    Introduction to today’s topic: best practices around document control 3:40 –    The key points to consider when initially creating the procedures for document control 4:44 –    Philippe discusses the role of technology in the document control process 5:36 –    The importance of training for document coordinators 6:56 –    Ericka covers the importance of preparing the backup document coordinators and keeping them up to date with established procedures 9:00 –    Martine provides some tips for companies moving from a manual system to an electronic system for control of documents 10:35 – Gretchen explains how to efficiently organize your documents 12:46 – Best practices around document revision 15:25 – The importance of using shared libraries such as SharePoint to ensure that users work on the same files 16:30 – How to ensure that documents are controlled from a training perspective 17:25 – Never keep a copy of a document on your own! 20:50 – The importance of doing a full mapping of the steps within your document control process before moving to a new process 22:25 – Philippe provides a final tip for our listeners 23:10 – Ericka thanks the guests and listeners   solabs-podcast@solabs.com

SOLABS QM Insights
Level 1 Service Level Agreement (SLA) with Gretchen and Philippe

SOLABS QM Insights

Play Episode Listen Later Oct 20, 2020 23:15


The QM Insights podcast show is back on its mission to help SOLABS’ clients learn from experience, continuously improve and do more with less. This week on the show, Ericka Moore returns as your host! She is joined by SOLABS’ CEO Philippe Gaudreau and SOLABS’ Product Specialist and Head Trainer Gretchen Dixson. In today’s episode, the team has a conversation on SOLABS’ new Level 1 Service Level Agreement (SLA). They explain why it was created, the advantages for our clients and how some of them currently use their Level 1 banks of hours. The guests also exchange on the new Workflow Report and a new article by Philippe titled: SOLABS’ Promises.   Key Takeaways 0:59 – Ericka introduces today’s guests – Gretchen Dixson and Philippe Gaudreau. 1:35 – Ericka explains the SOLABS’ Knowledge Base and how to access it. 2:19 – Gretchen introduces the new Workflow Report available with 10.8. 3:31 – Who will want to use the Workflow Report? 5:20 – Philippe discusses SOLABS’ promises to our clients and where to learn more on this topic. 7:21 – Ericka explains why SOLABS now offers a Level 1 SLA. 8:44 – What’s included in the Level 1 SLA and how does it work? 10:12 – What are the advantages of the Level 1 SLA for our clients? 11:50 – We can now provide custom built reports! 12:58 – Gretchen shares her experience providing Level 1 Support so far. 14:40 – Gretchen explains the importance of providing hands-on learning opportunities. 18:51 – Philippe details our partnership with Nexgen Analytics and how this impacts our reporting capabilities. 21:28 – Philippe explains where to find more documentation on our Level 1 SLA. 21:50 - Ericka thanks the guests and listeners and mentions how to reach her with comments and suggestions.

key takeaways life sciences sla level1 service level agreement solabs
SOLABS QM Insights
Ericka's Return! with Philippe, Martine, Kevin and Ericka

SOLABS QM Insights

Play Episode Listen Later Oct 6, 2020 22:54


This week on the podcast, Etienne Langlois, SOLABS’ Marketing Coordinator is back as your host! He is joined by Philippe Gaudreau, SOLABS’ CEO, Martine Boire, the team’s Head of Product and Quality Management, Kevin Byrne Langlois, SOLABS’ Head of Engineering and Ericka Moore, SOLABS’ Head of Client Success. Today, the team will discuss frequently asked questions about SOLABS, new resources available for clients on SOLABS’ Knowledge Base and more. They will also chat about Ericka’s return in the SOLABS team after a prolonged leave and how this will impact our clients’ lives!   Key Takeaways: 0:47 – Etienne introduces today’s guests: Philippe, Martine, Kevin and Ericka! 1:57 – Martine explains how many curriculums and training activities can be tied to a single document. 3:19 – Philippe explains what are the different levels of accesses to SharePoint and how they can be changed. 5:21 – Can users segregate the different libraries within SharePoint by user? 7:33 – Philippe explains what are the limits on the amount of user accounts, and how can this be changed? 10:15 – There will never be a case where a company tried to add a new user and is blocked because they are limited by their contract. 11:05 – Kevin details the process of preparing for a SOLABS intervention. 14:29 – Martine introduces her guide on setting due dates on document workflows. 15:38 – Ericka discusses her role  within SOLABS moving forward. 17:32 – Ericka shares her thoughts on the current pandemic and what it’s taught her. 19:45 – The team expresses their feelings regarding Ericka’s return. 21:19 – Etienne explains that Ericka will take back the role of show host for the QM Insights podcast moving forward. 21:50 – Etienne thanks all listeners and invites them to reach out to the team at solabs-podcast@solabs.com with any questions and/or suggestions.

SOLABS QM Insights
The QM Insights Podcast is Back! with Philippe, Martine and Gretchen

SOLABS QM Insights

Play Episode Listen Later Sep 22, 2020 16:24


This week on the podcast, Etienne Langlois, SOLABS’ Marketing Coordinator is your host! He is joined by Philippe Gaudreau, SOLABS’ CEO, Martine Boire, the team’s Head of Product and Quality Management and Gretchen Dixson, SOLABS’ Head Trainer and Product Specialist.  Today, they are trying out a new conversational format for the show! The team will discuss frequently asked questions about SOLABS, new resources available for clients on SOLABS’ Knowledge Base and more.   Key Takeaways: 0 :45 – Etienne introduces today’s guests: Philippe Gaudreau, Martine Boire and Gretchen Dixson. 1:44 – The new show structure is revealed! 2:24 –Where can our users view the workflows for each of our QM Apps. 3:13 – How can our users access the Knowledge Base to find their SOLABS related answers 4:04 – Etienne explains how to log into your production and validation URL from solabs.com 4:53 – Martine explains that approvers cannot be removed during an approval workflow. 6:15 – Martine details the process of modifying active activities 9:05 – The differences between the Eroom and the Knowledge Base 11:10 – Philippe talks about the new Level 1 Support Agreements 14:00 – The team share their thoughts on the new conversational format. 15:45 – Etienne thanks the guests

SOLABS QM Insights
SOLABS Laboratory Investigation Request Process (LIR QM APP) with Gretchen Dixson

SOLABS QM Insights

Play Episode Listen Later Mar 24, 2020 17:45


This week on the podcast, Philippe Gaudreau, the CEO and founder of SOLABS, is once again joined by frequent guest, Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS!   Today, they will be discussing SOLABS’ laboratory investigation request process (or LIR process). Gretchen explains how the LIR process ensures the documentation of everything within the laboratory investigation, the differences between the deviation process (in terms of capturing lab investigations) vs. the LIR process, and gives a detailed step-by-step of everything that is involved in the LIR process.   Key Takeaways: [:25] About today’s episode. [:36] Philippe welcomes Gretchen back to the podcast. [:43] An update on SOLABS’ operations and podcast in response to the COVID-19 pandemic. [2:08] About today’s topic: the LIR process. [2:28] Gretchen explains how the LIR process ensures the documentation of everything within the laboratory investigation. [3:10] Gretchen explains the differences between the deviation process in terms of capturing lab investigations vs. the LIR process. [4:49] Gretchen details the steps that are involved in the LIR process. [7:02] Gretchen explains the next steps after the laboratory incident has been reported and documented. [8:43] Gretchen describes steps 5 and 6 of the LIR process: laboratory investigations and manufacturing investigations. [10:06] Can additional testing be added and recorded in this process? [12:00] Gretchen explains how this app is linked to other processes in SOLABS QM. [13:08] Where to access the LIR QM APP user guide on SOLABS’ Knowledge Base. [13:53] How this QM APP helps with making sure to follow-up with due dates. [15:42] Philippe thanks Gretchen for being on the show! [16:06] Philippe thanks listeners for continuing to tune in to the podcast.   Mentioned in this Episode: SOLABS QM 10 Lab Investigations Process (P0055) docs.SOLABS.com SOLABS-Podcast@SOLABS.com  Philippe Gaudreau on LinkedIn Gretchen Dixson on LinkedIn

SOLABS QM Insights
Deviations Process App with Gretchen Dixson

SOLABS QM Insights

Play Episode Listen Later Mar 10, 2020 13:07


In today’s episode, your host Philippe Gaudreau, the CEO and founder of SOLABS, is joined by a frequent guest of the show — Gretchen Dixson, the Senior Product Specialist and Head Trainer at SOLABS!   Today, they will be taking a look the Deviations Process App (P0054) used for deviations in the context of the GxP pharmaceutical environments. Gretchen covers the main steps within the deviation process and what they’re being used for,  the items that are linked to deviation, which reports are available for this process, whether or not deviations can be used for lab investigations, and where to learn even more about this process after listening to the show!   Key Takeaways: [:24] About today’s episode. [:50] Philippe welcomes Gretchen back to the podcast! [1:15] Gretchen explains the main steps within the deviation process and what they’re being used for. [5:35] Gretchen highlights the convenience of initiating a child process (dependent or related) from within an ongoing process. [6:32] What other items are linked to deviation? [7:36] Which reports are available for this process? [9:04] Where users can find more information on this process. [10:06] From Gretchen’s experience, has she seen deviations used for lab investigations? [11:24] Philippe thanks Gretchen for joining the podcast and wraps up this week’s episode! [11:58] Philippe reminds listeners that SOLABS’ new website and knowledge base is now available!   Mentioned in this Episode: SOLABS QM 10 Deviation Process (P0054) SOLABS QM 10 Lab Investigations Process (P0055) SOLABS-Podcast@SOLABS.com  Philippe Gaudreau on LinkedIn Gretchen Dixson on LinkedIn docs.SOLABS.com

Automating Quality
Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1

Automating Quality

Play Episode Listen Later Mar 3, 2020 20:14


Welcome to the 35th episode of 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 show is pretty exciting! Mandy is going to be revisiting a topic that Automating Quality covered a bit last season around the GCP space. Joining her to discuss this topic is a veteran guest of the show who previously introduced the GCP topic — Nathalie Bourgouin! Nathalie is the Vice President of Compliance at Skillpad, which is a sister company of SOLABS. With nearly 30 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies.   Nathalie is kicking off this episode as the first in a four-part series around GCP inspection readiness from a phased approach perspective. Each of the four episodes will take a look at inspection readiness from four different stages, with the first one being the ‘Initiation’ phase.   For those that have yet to be involved in an inspection or in inspection readiness planning, this episode will be especially beneficial!   Key Takeaways: [:33] Mandy introduces this episode’s topic. [1:18] Nathalie Bourgouin introduces herself and provides a background of her career. [2:29] Nathalie further explains the topic for today’s episode and the content the full four-part series will cover. [3:07] Nathalie explains what inspection readiness truly refers to. [5:04] What are the first steps you should take when a regulatory agency comes knocking at the door? [7:09] Nathalie further defines the Initiate stage and explains why it is so critical. [8:37] How is an inspection “confirmed”? [10:11] Nathalie breaks down the Initiation stage from a task perspective. [12:11] How does Nathalie identify the key players? What does the vetting process look like and how does she assign those roles? [13:26] How Nathalie ensures all team members are feeling ready and comfortable for the inspection. [15:43] Once the inspector has arrived, what should you expect? [17:12] Mandy wraps up the first episode in the four-part series!   Mentioned in this Episode: Skillpad Nathalie Bourgouin’s LinkedIn Mandy.Podcast@Solabs.com

The WatchWithUs Podcast
WWU visits the Worn & Wound Wind Up 2019 (Part 1)

The WatchWithUs Podcast

Play Episode Listen Later Nov 11, 2019 13:29


John and Ricardo from WatchWithUs visit the Worn & Wound Wind Up Watch Fair 2019! (Part 1) The Worn & Wound Wind Up is one of the best watch shows in the world (in our opinion). With dozens of great brands and fantastic people, it is a unique opportunity to get hands on with great watches and speak directly with the brand owners. John & Ricardo interview some of the exhibiting brands and find out about the new watches being displayed at the show. The brands interviewed in this episode are... SoLabs Website: https://www.SoLabs.co Instagram: https://www.instagram.com/solabs.co Astor & Banks Website: https://www.astorandbanks.com Instagram: https://www.instagram.com/astorandbanks Farer Website: https://usd.farer.com/ Instagram: https://www.instagram.com/FarerUniversal/ Zodiac Watches Website: https://www.zodiacwatches.com/ Instagram: https://www.instagram.com/zodiacwatches/ Christopher Ward Website: https://www.christopherward.com/ Instagram: https://www.instagram.com/chriswardlondon/