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In this episode of Software Quality Today, I delve into the transformative power of ArchiveFlow in the pharmaceutical industry. Titled "ArchiveFlow - Stop Moving Everything Forward," this episode explores how two global pharmaceutical giants revolutionized their data governance strategies. By choosing selective data migration over the costly and risky "move everything forward" approach, these organizations achieved a staggering $30 million in five-year value, a 60% reduction in migration costs, and an 18x return on investment. Discover how intelligent data governance not only streamlines operations but also enhances AI readiness and sustainability. Join me as I unpack the compelling case study of ProcellaRX's ArchiveFlow and its impact on modernizing Application Lifecycle Management.

Enjoy 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 integrating technology across diverse sectors.-Strategies for scaling startups and navigating venture capital.-The importance of community, health equity, and advocating for women's rights.-Leadership philosophies and the art of building industry partnerships.-The origin of the HLWF Alliance, and what they have in store for the future. This episode isn’t just a conversation; it’s a call to action for innovators, entrepreneurs, and advocates ready to make a mark. *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

This 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 AI-powered devices, the importance of collaborative education, the criticality of developing a Quality by Design program, and the impact of diverse perspectives in the Life Sciences industry. Discover the keys to innovation, efficient processes, and nuanced risk management in this insightful conversation with Dori Gonzalez-Acevedo and Jason Secola. Share with a friend or colleague and subscribe wherever listen to podcasts! *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Welcome 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, a custom software, web and mobile application development company. She is also the co-founder of OneTribe, an HR management platform for hybrid and remote teams. She lives in Brooklyn with her husband and two daughters.Follow Natalie on LinkedIn here and reach out to let her know you listened!  *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Join 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 products and secure their supply chains through the delivery of innovative analytics and business intelligence - all while creating a new marketing channel in which to engage their customers.Connect with Richard on LinkedIn here and learn more about GPAS here. *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

We'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 and integrating the entire validation ecosystem.Please follow Phil on LinkedIn here and don't forget to  *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Join 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 Modernizing 21 CFR Part 11” conference to spend some time dissecting the event and some of the content presented. Some themes included where and how 21 CFR part 11 fits into the current landscape relative to its inception in 1997, the state of CSV at many organizations, as well as other relevant industry regulatory codes and guidances that come into play both from an FDA perspective, as well as global equivalents. What two better people to have a conversation to share insights and summarize a content rich event?Follow Steve on LinkedIn here and be sure to check out the ValGenesis podcast upon its triumphant return.In the meantime, please enjoy this episode and don't forget to subscribe, rate, and share. *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In 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 values.Tune into hear Dori and Jillian discuss a variety of topics around the importance of fostering and developing growth within an organization to achieve operational efficiencies, and the recipe that United Wholesale Mortgage has developed to do just that.Follow Jillian on LinkedIn here and don't forget to rate, subscribe, and share this podcast with friends and colleagues! *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

In this episode of Software Quality Today, I sit down with Sree K, a seasoned expert in risk-based validation and automation within the life sciences industry. With over 18 years of experience, Sree challenges traditional validation methods and emphasizes the importance of embracing the new Computer Software Assurance (CSA) guidance. We explore how a risk-based approach can enhance efficiency and compliance, particularly for small and mid-sized pharma companies. Sree shares insights on navigating the complexities of validation across diverse roles, the value of automation, and the necessity of ongoing education for quality teams. Join us for an engaging discussion that rethinks the future of validation in our industry.

In 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 opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

This 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, shifting towards effectiveness measures of training, and, perhaps most importantly, moving towards a people-centric learning model as part core business operations.Enjoy the episode and please don't forget to rate, subscribe and share!  *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Dori 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 what’s not – one way to do that as efficiently as possible is with the use Open-Source technology/software rather than having to build their own.  As an industry we need to be able to shift to use S.O.U.P. where possible in order test our hypotheses and potentially save critical time to market as a competitive advantage. This often comes by using open-source technology but how can we if we don’t have ultimate control over that software? S.O.U.P may not be a term you may not be familiar our guest today clarifies, puts it into perspective and how it could be utilized in a heavily regulated industry such as life sciences when it’s fit for purpose.  Sware LinkedIn Sware Website  *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

As 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 forget to rate and subscribe wherever you listen to podcasts!You can reach out to connect with James on LinkedIn here.For more click on Don McPherson's work with Aspirational Masculinity and Alexander Prout and I Have the Right To *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Recorded 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 LinkedInConnect with Dori on LinkedIn *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX

Project 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 LinkedInMustardSeed's LinkedInMustardSeed's WebsiteSteve Curry, PMP has a passion and calling to help lead projects, programs, teams, and businesses to tremendous success by increasing their maximum potential of operating efficiency through the utilization of program management best practices. He is equally passionate about communicating with clients when project risks and issues arise. It comes from Steve’s extensive experience and background in managing projects and programs of all sizes and his experience in finance, sales, business analysis, and management. Steve has had the benefit of working in PMOs in four different industries. Having spent nearly 20 years in the field, he has dedicated himself to collecting, organizing, compiling, and implementing today's best PM practices. Today Steve leads MustardSeed as Founder and CEO. MustardSeed provides project management services to life science companies. *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 employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.This is a production of ProcellaRX