Sivakumar Kalidoss

Compliance Group Inc.
Associate Director - Enterprise Digital Quality & AI Validation
Sivakumar Kalidoss is an Associate Director specializing in Enterprise Digital Quality, Computer Software Assurance (CSA), and AI validation within the regulated life sciences industry. He has extensive experience leading validation and compliance initiatives for GxP-regulated systems, including AI-driven platforms, pharmacovigilance systems, quality management applications, and enterprise digital transformation programs. His work focuses on applying risk-based validation frameworks, lifecycle governance, and continuous compliance strategies to emerging AI/ML technologies in regulated environments. Sivakumar is also an ISPE guidance document reviewer and an active contributor to industry discussions related to AI governance, GAMP 5, CSA, and digital quality transformation.

Related Articles

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iSpeak Blog
When AI Meets GxP: A Risk-Based Framework for Continuous AI Validation in Life Sciences

How do you validate a dynamic system? In regulated life science environments, AI is now operational as part of a variety of applications, such as batch disposition assistance, pharmacovigilance signal detection, deviation filtering, and clinical trial data reviews. However, with accelerating deployments, there is an essential question which will need to be addressed: how can we apply current...