Software Quality Today
28 episodes - English - Latest episode: 27 days ago - ★★★★★ - 3 ratingsExplore the world of software testing and computer systems validation for regulated industries. The who, what, when, why and how of best practices within software quality assurance.
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Episodes
From Silicon Valley to Health Alley: A Tech Pro’s Healthcare Journey, with Rashmi Rao
March 29, 2024 07:00 - 51 minutes - 35.4 MBEnjoy this awesome discussion with Rashmi R. Rao and Dori Gonzalez-Acevedo, as they unravel their journeys through entrepreneurship, innovation, and STEM advocacy in the dynamic world of healthcare technology. Full of insights on leveraging technology to enhance lives, building impactful communities, and the vital role of diversity and leadership in shaping the future of healthcare and technology, they discuss: -The transformative power of female empowerment in STEM. -Crucial insights on i...
Quality by Design in the AI Era: Innovating Quality in Life Sciences, with Dori Gonzalez-Acevedo
October 31, 2023 07:00 - 49 minutes - 34.2 MBThis episode was recorded live from the KENX Medical Device Validation University in Anaheim, CA! This time around, Jason Secola interviews your usual host, Dori Gonzalez-Acevedo to give a conference recap, as well as field some questions submitted by our LinkedIn audience. Tune in as they dive into a variety of topics, not least of which is the world of AI and Software Quality in Medical Devices and the Life Sciences industry. Some key points discussed were the FDA's increasing approval of...
From QA Tester to CEO, with Natalie Kaminski
September 29, 2023 07:00 - 52 minutes - 36.3 MBWelcome to another episode of Software Quality Today! On today’s show, Dori welcomes Natalie Kaminski. Amongst other things, they chat about Natalie’s path from QA Tester to CEO of a technology company, and how her background in QA shaped her approach to launching and running a software development company. With more than 20 years of experience in the technology industry, Natalie is a dynamic and resourceful web and mobile technology entrepreneur. She is the CEO and founder of JetRockets,...
Exploring OpenText GPAS in Life Sciences, with Richard Lightfoot
August 25, 2023 07:00 - 48 minutes - 33.2 MBJoin us in welcoming Richard Lightfoot for his first appearance on the show! Rich leads the sales and business strategy development of OpenText Global Product Authentication Service, or GPAS, in the Americas and is responsible for channel partner and new market opportunities. Dori and Rich have a great discussion around the applicability and importance of GPAS within the life sciences industry. GPAS is based on unit level serialization of finished goods and helps brands protect their produ...
Digitizing and Integrating the Validation Ecosystem, with Phil Jarvis
June 30, 2023 07:00 - 28 minutes - 19.7 MBWe're excited to welcome Director of Integrated C&Q and Kneat Services at VEQTOR, Phil Jarvis! Phil is extremely active in the life sciences community and is a staunch advocate for modernization and improvement in our industry backed by a wealth of experience and insights. I have to apologize in advance for the audio. We had a bit of a technical issue when recording this live, but trust me, this conversation is well worth a listen as Dori and Phil dive deep on the importance of digitizing ...
A Conference Wrap-up with Steve Thompson: KENX "Lean Validation - Implementing CSA and Modernizing 21 CFR Part 11"
May 24, 2023 07:00 - 51 minutes - 35.1 MBJoin us as we welcome Steve Thompson in a special swap-cast episode that will be published here to Software Quality Today, as well as to the soon to be revamped and relaunched podcast from ValGenesis that Steve will be hosting. Steve is a highly respected, extremely involved figure in the life sciences community and is currently the Sr. Product Marketing Manager at ValGenesis. In this episode, Dori and Steve sat down after several days of the KENX “Lean Validation – Implementing CSA and ...
Bringing out the Best, with Jillian Mantua
May 19, 2023 14:00 - 53 minutes - 37.1 MBIn this episode, we welcome VP of of IT Training, Growth & Development at United Wholesale Mortgage, Jillian Mantua. Jillian is passionate about developing and guiding teams through the uncharted territories that come with organizational transitions and rapid growth by leveraging best practices across all industries. She focuses on identifying what and how to do things differently than current day practices, how to bring out the best in employees, and true alignment with organizational val...
Rethinking Validation, with Sree K
April 28, 2023 07:00 - 46 minutes - 32.3 MBWelcome back to another episode! Today, Dori sits down with Sree K, a life sciences industry professional with over 18 years experience that spans roles in testing, validation, IT, Business, and Quality. As an expert in test automation, Sree is a huge advocate for automation in validation and modernizing our approaches to software compliance. Sree is also very active on LinkedIn, providing his followers with unique and insightful life sciences related content, and illustrating what an excit...
A Journey of Progress, Preservation, and Innovation, with Dr. Sue Black
March 31, 2023 05:00 - 47 minutes - 32.7 MBIn this fantastic episode, Dori Gonzalez-Acevedo and Professor Sue Black OBE get into a highly engaging discussion around Sue's personal journey in tech and beyond, the programs she's established to support women in tech, and her role in preserving Bletchley Park. Please don't forget to subscribe, rate and share! Connect with Sue on LinkedIn: Professor Sue Black OBE *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and...
The Effectiveness of Quality Training, with Danielle Duran
March 24, 2023 07:00 - 48 minutes - 33.1 MBThis episode we are excited to welcome to the podcast Danielle Duran, Director of GxP Compliance and Training at Aimmune Therapeutics! As fellow advocates for education and continuous enablement in life sciences, Dori and Danielle share their insights on the current state of learning in our industry, and where we can do better to support more effective outcomes in IT and Quality organizations. Listen in now to learn more a bout leveraging effective learning to support quality culture, shift...
Unlocking the power of S.O.U.P with Jackie Davidson
January 20, 2023 15:00 - 57 minutes - 39.3 MBDori Gonzalez-Acevedo Co-Founder & CEO of ProcellaRX welcomes Jacqueline Davidson, Owner of Davidson QA Consulting and Head of Regulatory Intelligence and Innovation at Sware, Inc to Software Quality Today. Download now to listen to Jackie’s perspective on S.O.U.P, (Software of Unknown Providence) what is it and how can you leverage it within your organization. Innovation is driven by scientists; they test the limits of their ideas as quick as possible to see what’s possible and vet out w...
KENX CSV and CSA University Wrap-Up, with James Northup
December 11, 2022 08:00 - 23 minutes - 16.4 MBAs we wrap up a very successful week at the highly attended KENX Computer Systems Validation and Software Assurance University conference in Philadelphia, PA, we are joined by James Northup from Tricentis. Dori Gonzalez-Acevedo sat down to discuss some key takeaways from the event for those unable to attend in person and recap some of the highlights from presentations promoting change in our industry, spanning CSV, gender equality and more. Join us for this great conversation and don't forg...
Case for Quality, with Cisco Vicenty
September 02, 2022 07:00 - 24 minutes - 17 MBRecorded at the KENX GMP University in San Diego, Dori welcomes special guest and FDA Case For Quality Program Manager, Cisco Vicenty. They sit down together to to recap some important takeaways from the conference, as well as to discuss what is being done to enhance collaboration between the industry and regulators to help drive a shift in mindset and advance innovation in life sciences. Please enjoy this special episode and don't forget to rate and subscribe! Connect with Cisco on Linked...
Building Effective Project Management Teams, with Steve Curry
August 12, 2022 07:00 - 53 minutes - 37 MBProject management always has and always will be a crucial function in any organization. In life sciences, that function is changing. Project Managers need to adapt to ensure their teams continue to deliver successful projects in the face of a shifting technology and methodology landscape, while still ensuring compliance. Join us this episode for a fantastic interview with Project Manager extraordinaire, and Founder and CEO of MustardSeed, Steve Curry! Steve Curry's LinkedIn MustardSeed's L...
A Critical Look at Computer Software Assurance (CSA): Is it Really a Thing?
July 01, 2022 07:00 - 1 hour - 49.7 MBA risk-based approach to Computerized System Validation has been around for over 20 years, so what's the hype about CSA? Join us in this episode as we are joined by our amazing guest, Dr. Bob McDowall, to explore this question. Bob McDowall is an analytical chemist with 50 years of experience including 15 years working in the pharmaceutical industry and 29 years as a consultant to the industry and suppliers to the industry. He has been involved with the validation of computerized systems fo...
Artificial Intelligence and Machine Learning in Life Sciences, with Eric Staib
February 04, 2022 08:00 - 42 minutes - 29.2 MBArtificial Intelligence and Machine Learning are being used to great results in a variety of ways across numerous industries, but what does it mean for the Life Sciences industry? How can Life Sciences teams that want to stay on the cutting edge begin to practically incorporate AI/ML to drive better, more efficient results across their organizations? If you're looking for answers, you've come to the right place. Give this podcast a listen to hear subject matter expert, Eric Staib, share his...
Strategic and Risk-Based Testing, with Ajay Pandey
January 11, 2022 08:00 - 49 minutes - 33.8 MBDori welcomes long-time colleague and Sr. Manager of TCoE at Biogen, Ajay Pandey to the podcast. With extensive knowledge of application testing and software quality in Life Sciences, Ajay shares his insights on setting up a strategic Testing Center of Excellence framework, as well as the importance of incorporating risk-based testing. Ajay is a Senior IT professional with over 19 years of progressive experience in management and governance of Application Lifecycle Management/SDLC toolsets ...
Breaking Down SAP Testing and More, with Micro Focus Expert, Don Jackson
December 16, 2021 06:00 - 1 hour - 50.4 MBDori is able to grab some time with Micro Focus SAP expert, Don Jackson. From automating SAP, to process management, to streamlining maintenance of components and assets, Don has a variety of insights he shares based on his years of experience. In addition, he is able to share some extremely valuable tools that Micro Focus brings to the world of SAP testing/maintenance which help their clients in the realm of SAP and beyond. General SAP testing questions? SolMan questions? S4HANA questions...
Raising the Software Quality Bar at the Coffee Bar, with Ken Shitamoto
December 13, 2021 06:00 - 22 minutes - 15.8 MBIn this episode, Dori sits down with fellow CSV and CSA guru Ken Shitamoto for some outdoor, morning coffee on the final day of the KENX Computer Systems Validation and Software assurance conference. Together, they share their insights not only on CSV/CSA, but the overall state of software quality in Life Sciences and what we as industry professionals can do to collectively raise the bar as we move into 2022. As mentioned in the episode outro, they discuss some recent comments from Cisco V...
CSA and CSV from a Beach in SD, with Sagax Team CEO, Rohit Tyagi
December 09, 2021 09:00 - 34 minutes - 23.6 MBJoin us from a beach in San Diego, California, at the KENX Computer Systems Validation and Software Assurance conference. In this episode, Dori is joined by industry colleague and subject matter expert, Rohit Tyagi, President and CEO of Sagax Team. They discuss some of the presentations and topics that have been covered at the KENX conference this year, as well as general thoughts, challenges, and successes that folks are currently experiencing related to CSV modernization and CSA adoption ...
A Wrap-Up from the ISPE Annual Meeting & Expo, with Dori Gonzalez-Acevedo and Jason Secola
November 07, 2021 07:00 - 21 minutes - 15.1 MBIn this quick episode following our attendance at the ISPE Annual Meeting and Expo, I sat down with our host, Dori Gonzalez-Acevedo, to do a bit of a post-conference wrap-up episode. We discuss some of the highlights of the conference relating to software quality, common themes we heard, issues that our industry needs to address, and the overall takeaways from the event. Tune in to hear Dori's thoughts and don't forget to rate and subscribe where you get your podcasts! *Disclaimer: Podcast...
A Culture of Change in IT and Beyond, with Lydia Castillas
October 29, 2021 04:00 - 55 minutes - 37.8 MBJoin Dori as she interviews Lydia Castiallas, the Southeast Sales Leader for Enterprise Accounts at Micro Focus - but fear not, dear listeners! This is not a sales conversation or a sales pitch. Lydia brings a wealth of experience to the table and some valuable insights on the current state of IT, as well as important considerations for staying ahead in an ever-changing landscape. Later in the conversation, they spend some time discussing the diversity and inclusion groups that Lydia is inv...
Building it Up, with Tx3 Co-Founder, Eric Toburen
September 06, 2021 18:00 - 33 minutes - 23.2 MBEric Toburen, Co-Founder of Tx3 Services, joins Dori in this episode to discuss what it took to build Tx3, the mentality that we bring to our clients, and the excitement of being considered a leading provider in the Life Sciences industry. That's not all, though! Give it a listen to hear the full conversation. *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their em...
"A New Better" in Biotech with Mike Fannon
July 27, 2021 07:00 - 1 hour - 42.3 MBIn this episode, Dori is joined by longtime friend and colleague, Mike Fannon, the CEO of BioIT Solutions. With Mike's extensive career in the Biotech space, ranging from manufacturing through SQA, they discuss the evolution of the Biotech industry, the trends of today, the impacts of COVID, and how Mike and the BioIT Solutions team are enabling "a new better" for the Biotech world. Jump in and give it a listen! *Disclaimer: Podcast guest participated in the podcast as an individual subject...
Get to Know the Host: Dori Gonzalez-Acevedo
June 29, 2021 05:00 - 49 minutes - 33.8 MBBefore we get too deep into the run of this show, we thought it would be good to do an episode where you fine folks at home can get to know the host of Software Quality Today, Dori Gonzalez-Acevedo. I know why you can and should trust Dori as a true subject matter expert in our world of regulated software, and after this episode I'm sure you will too! *Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they ...
Navigate Testing Software as a Medical Device: Ed Hein
May 25, 2021 05:00 - 43 minutes - 30.2 MBIn this episode, Dori interviews Ed Hein, Manager of Digital Validation and Verification at Lifescan. With years of experience in the medical device field, Ed shares his thoughts on the challenges and best practices for testing software as a medical device, as well as some insights on the current state and future of the industry. Take a listen to get the scoop! *Ed has agreed to participate in this podcast as an individual subject matter expert, and his views and opinions do not necessaril...
Our CEO Makes the Show: Jason Tepfenhardt
April 20, 2021 15:00 - 42 minutes - 29.1 MBIn today’s episode, Dori interviews longtime friend, colleague, and Tx3 Co-Founder/CEO, Jason Tepfenhardt. From his start back in the labs all the way through forming Tx3, they’ll discuss everything in between. Through providing an honest view of himself, Tx3, and lessons he’s learned along the way, Jason shares his ideas on what he wants for not just the Tx3 team, but also for our clients, and the Life Sciences industry as a whole. We were even graced by a brief, but special guest appear...
Moving the Needle: CSV and SDLC Modernization in Life Sciences
February 05, 2021 05:00 - 1 hour - 78.8 MBIt’s never been more apparent that change is happening all around us. How we and our organizations choose to act and adapt to those changes will set us apart from those around us. Join us for an exploratory conversation as we dive into this theme with thought leaders in IT and QA at some of the top Life Sciences organizations in the industry. In this great thought leadership panel discussion, our host, Dori Gonzalez-Acevedo, VP of Strategic Solutions at Tx3 Services, will Interview: Aly...