Immutable Trust for Life‑Saving Science: Blockchain in Regulated Pharma

Harshitkumar Dineshkumar Prajapati is the Senior Manager of IT Validation & Compliance at CRISPR Therapeutics, a pioneer in gene‑editing medicines. In this role, he is responsible for ensuring that all computerized systems adhere to the strictest global regulatory standards — including FDA 21 CFR Part 11, EU Annex 11, and GxP requirements — so that clinical data, manufacturing records, and quality controls are always accurate, complete, and audit‑ready. He brings to UN Blockchain Week a unique perspective from the front lines of life sciences: how blockchain can serve as the perfect immutable backbone for data integrity, regulatory compliance, and patient safety in an industry where trust is literally a matter of life and death.

With extensive experience in computer system validation, quality risk management, and IT audit execution, Harshitkumar has led validation programs across clinical trial platforms, laboratory information management systems, and enterprise resource planning tools. He understands that the pharmaceutical supply chain, clinical data pipeline, and electronic batch records are vulnerable to tampering, data gaps, and reconciliation errors — exactly the challenges that a distributed ledger can solve. By anchoring lab results, manufacturing logs, and chain‑of‑custody documentation to an immutable blockchain, he envisions a future where regulatory inspections can be completed in real time and patient‑level data remains provably unaltered. At UN Blockchain Week, he shares practical use cases for blockchain in pharmaceutical compliance, the roadmap for integrating DLT within existing quality management systems, and how validated blockchain solutions can accelerate drug development while enhancing public trust.