Webinar: CSA & Paperless Validation – Enhancing Compliance & Efficiency
On-demand webinar
CSA & Paperless Validation - Enhancing Compliance & Efficiency
Balancing compliance and operational efficiency is critical in today’s highly regulated environments. During this session, our hosts, Pratima Choudhary (Validation Lead, Billennium) and Jeff Ramos (Solution Engineer, ValGenesis), explored how Computer Software Assurance (CSA) and Paperless Validation are driving this balance by modernizing validation approaches.
CSA, a risk-based framework, allows organizations to focus on high-risk areas or critical software functions that directly impact patient safety, product quality, or data integrity while reducing the burden of excessive documentation and increasing overall efficiency. Coupled with paperless validation, these strategies streamline documentation, enhance data integrity by removing manual, error-prone processes, and provide real-time audit readiness, all while accelerating development timelines.
Watch this on-demand webinar and learn how CSA and Paperless Validation can help your organization achieve enhanced compliance and efficiency, ensuring both quality and speed, allowing your organization to thrive in today’s fast-paced regulatory environment.
What key topics will we cover?
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01
Overview of CSA and Paperless Validation
Introduction to the topic and its relevance in compliance.
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02
Key Compliance Issues
Identifying major regulatory challenges impacting daily operations.
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03
Benefits of CSA and Paperless Validation
How these methods enhance compliance and reduce operational costs.
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04
Ensuring Data Integrity and Efficiency
Best practices for implementing CSA and improving data integrity.
Pratima Choudhary
Validation Lead at Billennium
With 15 years of experience in computerized system validation, Pratima has a deep understanding of managing and executing validation processes across the pharmaceutical industry—from drug discovery to global operations. Highly skilled in regulatory compliance, she brings extensive expertise in navigating FDA, EMA, MHRA, 21 CFR Part 11, and GxP guidelines to ensure top-tier quality standards.
Outside of work, she enjoys playing tennis, traveling, listening to music, and spending quality time with her daughter. A seasoned participant in Spartan Races and Poland Business Runs, she balances a dynamic career with an active and adventurous lifestyle.
Jeff Ramos
Solution Engineer at ValGenesis
He has spent over 13 years as a Quality Specialist and Software Validation Engineer. He has worked across sectors, from bio-pharmaceuticals and start-ups to global companies, refining his software validation and quality assurance expertise.
Beyond his professional life in IT, he is deeply involved in the San Francisco Bay Area Theatre Community as a performer, collaborator, and creator. He also serves as the Head Coach and Lead Instructor at a fitness studio, where he helps individuals improve their physical and mental well-being.
In his spare time, he enjoys editing music videos, participating in Spartan Obstacle Races, and traveling the world. Passionate about continuous learning and improvement, he is excited to share practical insights into CSA and paperless validation with you in this webinar.
