RiskCortex

Eliminate the risk of
penalties from regulatory
non-compliance

Achieve regulatory compliance 75% faster with over 90% fewer errors using our AI Risk Agent

Risk Summary

Provides a smart, automated review of compliance risk impact on your organization by referencing millions of data points from regulations, cases, and scores. The system delivers an 75% time saving, scans over 12 global regulatory agency databases in a single search, and enables one-click compliance risk impact review generation.

Risk Consensus

Uses AI to deliver a consistent, structured, and contextual understanding of organizational risks and required mitigation activities, synthesizing information from hundreds of unstructured sources. Features include purpose-built AI for structured risk mapping, two-click delivery of risk validation plans and traceability maps, and intelligence to close risk information gaps.

Risk Mitigation

Automates the execution of risk validation, mitigation, documentation, and continuous monitoring, ensuring effective risk management. Key benefits include hindsight and intuition-led controls for risk impact reduction, execution of control tests in less than a minute, and continuous monitoring of risk controls.

Case Studies and Events

Cold Chain OEM: Smart Quality Management & Monitoring

Revolutionising Cold Chain Management in Temperature-Sensitive Industries.

October 17, 2024READ MORE

SCDM Brussels 2025

RiskCortex and LifeStream DSA are heading to SCDM Brussels 2025!

April 9-11, 2025READ MORE

Podcasts

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.

June 16, 2025

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.

May 04, 2025

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.

April 28, 2025

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.

Feb 24, 2025

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.

February 22, 2025

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.

February 08, 2025