Welcome to Day Three, the final day of ValConnect 2022!
We closed out the conference with incredible insights, top-tier speakers, and some thought-provoking Q&A sessions. Let’s recap!
Keynote: ValGenesis SMART
“In the growing chaos around us, it is urgent and essential that we be the change we seek in the world.” – Ajaz Hussain.
Our final keynote of the conference did not disappoint. Dr. Ajaz Hussain is an acknowledged thought- leader in the advancement of pharmaceuticals, regulatory science, and drug development, and a highly sought-after speaker and writer. For all those reasons, we were honored to have him deliver ValConnect 2022’s closing keynote address – ValGenesis SMART.
Dr. Hussain envisions ValGenesis SMART as a fractal approach to quality management and professional development at all levels of hierarchy – corporate, regulatory, and system. ValGenesis SMART is, therefore, a catalyst and a system for professional lifecycle management (PLMS), a way of thinking and planning to expand awareness of opportunities for change. Click on the video below to watch his insightful, inspiring presentation.
Wednesday’s Session Highlights
Here are some high-level takeaways from today’s 45-minute sessions. We plan to feature many of these sessions and links to their recordings in upcoming blog posts.
Session: Philips: Our Journey with ValGenesis
Today started with a powerful customer success story from Philips Healthcare, a global leader in intravascular diagnostic imaging and cardiovascular and endovascular therapies. Philips transitioned from a paper-based CSV system to the ValGenesis VLMS (Version 3.1) in 2016, then upgraded to Version 4.1 in 2021. According to QMS Manager Paul Dacosta, the drivers for going digital were to: increase efficiency and integrate with existing IT processes, including an Agile way of working; decrease cost; improve compliance; and standardize more than 35 local validation processes.
Implementing a critical system in a large global company comes with challenges. Paul explained how Philips and the ValGenesis team collaborated to resolve those challenges. Usage of the system has skyrocketed from 221 users in 2016 to 1,195 today. The company currently maintains 62,993 validation artifacts in the ValGenesis system!
Session: Introduction to iSEE™ from 4TE
Manual computer software validation (CPV) is reactive, repetitive, and has costly repercussions. In our first demo of the day, Sandra D. Silva, head of digital transformation at 4TE, showed us how to keep the risk up to date with the data and the data generated according to the risk through 4TE’s continuous process verification software system (iSEE Platform™). Through real-time monitoring, iSEE’s integrated risk and data approach provides a complete view of products through a structured method for generating, storing, analyzing, and managing information over time. Learn more about the features and functionality of iSEE.
Session: New Science Transformative Patient Outcomes
The biopharma industry has reached an inflection point. The rising costs of New Science and patient care, combined with rapidly advancing technology, have made it difficult for manufacturers to keep up with patients’ needs. New Science (a term coined by Accenture) is a category of innovation that delivers more precise and innovative treatments to target unmet patient needs, but it comes at a higher price. Drugs are expensive. Payers are under pressure. Government spending is rising. Prem Iyangar, associate director and head of India IT quality and medical devices technology at Accenture, outlined the path forward this morning. His solution demonstrates that New Science can deliver accessible, affordable, and transformative patient outcomes when built on well-defined outgrowth strategies that access emerging technologies like AI, extended reality, blockchain, NFTs, digital twins, and cloud computing.
Session: Seamless Integration for Lean Validation
In this popular Product Knowledge session, Director of Professional Service Yowvanaraj Gopal explained how ValGenesis’ REST API stack connects the ValGenesis VLMS to other GxP software systems commonly used by life sciences organizations, e.g., ServiceNow and Jira, to maximize data sharing and workflow efficiency. He also shared a fascinating integration case study of a global pharmaceutical company and how a single source of truth helped them manage and maintain a validated state.
Session: Best Practices for a Successful ValGenesis Implementation
Robert van der Laan, senior vice president of professional services at ValGenesis, has implemented software systems for over thirty years. He knows what works and what doesn’t. Today, he shared that knowledge with customers. Robert kicked off his session by outlining eight factors that all successful implementation projects share. Here are two: (1) define the scope of your project and stick to it and (2) ensure you have an internal project champion. Next, he revealed the seven most common implementation challenges and how to avoid them. Hint: Watch out for analysis paralysis; set decision deadlines and honor them. Finally, he outlined seven best practices for accelerating deployment. He wrapped up his session with the case study of a global medical device company that implemented ValGenesis for CSV in just over a month!
See You Next Year!
We encourage you to bookmark our blog and follow #ValConnect on social media for more conference-related content and updates. We hope you enjoyed this year’s conference and look forward to seeing everyone in-person next year. ValConnect 2023 will be held at the Hilton Clearwater Beach Resort & Spa in Clearwater, Florida, from Sept. 26-28.