Resources
Cold Chain OEM: Smart Quality Management & Monitoring
Revolutionising Cold Chain Management in Temperature-Sensitive Industries.
SCDM Brussels 2025
RiskCortex and LifeStream DSA are heading to SCDM Brussels 2025!
Beyond Compliance: AI Based Risk Assessment for Smarter Validation
In this Episode of Regulatory Risk Insights - Arun talks to John Patterson - CEO of Centenerian Technologies. John has over 30 years bio-pharmaceutical industry leadership experience at both MSD/Merck & Co and EMD Serono leading and delivering significant responsibilities in ensuring GMP and GCP regulatory inspection readiness. Mr. Patterson maintains active involvement with multiple ISPE and industry SIGs. John is a thought leader in how AI can help alleviate challenges in the current state of validation in Lifesciences, he resides with his family in Doylestown Pennsylvania.
Intelligent Automation - Driving Efficiency in Regulatory Compliance
Henal Shah - Lifesciences Client Partner at Persistent Systems and Gautam Hotti - CTO of RiskCortex provide pointers on how agentic AI has the ability to drive next level of efficiency gains in regulatory compliance.
Objectivity in Data Integrity and System Validation
A conversation with Dr. Santhosh Kumar - Head of Global Delivery and Operations & Ephicacy who talks of the issues with subjectivity and the need to prioritize objective, data-driven risk assessments for a higher standard in our clinical data integrity and system validation approach.
Role of 'Why' and Critical Thinking in Computer System Validation
Arun speaks to a acknowledged thought leader in the space of Computer Software Validation - Carolyn Troiano. She digs deep into the need for Critical thinking and why practical approaches including AI can be used to ensure Validation doesnt remain a compliance checkbox, but an exercise of improving system reliability continously.
Challenges of using AI in Life Sciences System Validation
Talking to Raji Bijur of LifeStream DSA, Arun and Raji explore the challenges that lie in organisations looking to exploit AI in system validations. While the benefits are well known, Raji describes some of the key considerations to negotiate the pitfalls of AI use in this area.
Role of AI in Computer System Validation
In this podcast in conversation with Arun in conversation with Raji Bijur - CSV Capability Director LifeStream DSA, explores the role of AI in how it is impacting lifesciences computer system validation. In this fascinating short talk, Raji talks of the proactive approach that Validation 4.0 that AI can enable.