Senior, independent support for regulated organisations deploying and operating systems in GxP environments: CSV, data integrity, governance, inspection readiness and AI governance for regulated systems.
Risk-based validation strategy, lifecycle planning and proportionate assurance, CSA-aligned, traceable and inspection-defensible.
↗ 02ALCOA+ gap assessment, risk-ranked remediation and sustainable BAU controls across the data lifecycle.
↗ 03Applicability decisions, gap assessments and evidence packs built for inspection scrutiny, not just internal sign-off.
↗ 04Supplier oversight, change governance, periodic review and operational controls for regulated SaaS platforms.
↗ 05Security controls aligned with assurance and auditability, integrated with validation, not bolted on afterwards.
↗ 06Readiness assessments, evidence narrative and targeted remediation to reduce inspection friction before it becomes an observation.
↗ 07ISO 9001-qualified internal audit capability: supplier qualification, CSV package audits, FDA 483 response and CAPA ownership across regulated life sciences.
↗ 08Risk assessment, validation strategy, change control and inspection-ready evidence for AI and algorithmic systems in regulated environments. Emerging regulatory requirements. Proven validation principles.
↗Fixed-scope compliance triage, document review and recovery engagements, offering a defined way in before committing to a larger programme.
Engagement experience spans the full breadth of GxP computerised systems, from laboratory and manufacturing platforms to enterprise and cloud-hosted applications.
The validation strategy and documentation Ashok developed were thorough, well-structured, and proved to withstand customer audits and regulatory scrutiny. He combines deep regulatory knowledge with a practical understanding of how regulated organisations operate.
Jelle ten Hoeve · Co-Founder, Data Curators BVAshok consistently demonstrated deep expertise while always taking a pragmatic, risk-based approach to decision-making — across systems ranging from robotic automation to IT quality remediation. I would highly recommend him.
Laur Oltean · QA/CSV Consultant · LRQA Lead Auditor ISO 9001:2015A focused 30-minute conversation to understand your environment and where the risk actually sits. No commitment.