Data Integrity for Global Drug Development

A HealthSec Alliance™ Case Study

Client: Global Pharmaceutical Company

Challenge

The client’s development and manufacturing teams needed to strengthen digital data integrity across hybrid IT, OT, and cloud environments. Global operations relied on fragmented systems that made it difficult to prove data authenticity, completeness, and traceability for Chemistry, Manufacturing, and Controls (CMC) data.

Regulators increasingly expect verifiable proof of data provenance under FDA 21 CFR Part 11, EU MDR, GxP, and ICH E6. Existing QMS, LIMS, and MES platforms lacked the capability to deliver cryptographically verifiable assurance without disrupting validated workflows.

Key objectives:

• Validate and trace CMC and clinical data from source to submission

• Detect tampering or corruption across digital pipelines

• Automate audit evidence generation and lifecycle validation

• Support SaMD and AI-enabled trial platforms

Solution

The HealthSec Alliance™ implemented a blockchain-anchored data verification layer within the client’s development infrastructure to enhance data authenticity and transparency. The lightweight system created tamper-proof, time-stamped records that could be independently verified without exposing proprietary data.

Core activities:

• Connected secure APIs to laboratory, manufacturing, and clinical systems

• Captured metadata and hashes for each record event and anchored them to an immutable ledger

• Integrated data provenance workflows aligned with FDA 21 CFR Part 11, ISO 13485, Annex 11, and ICH E6(R3)

• Built a compliance dashboard enabling cryptographic verification and audit-ready reporting

Technical & Regulatory Framework

• Quality & Risk Standards: ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366

• Global Regulations: FDA 21 CFR Parts 11, 803, 806, 820; EU MDR 2017/745; IVDR 2017/746

• Privacy & Security: HIPAA, GDPR, HITECH, and U.S. state data-privacy laws

Outcomes & Impact

• Immutable Evidence: Verified 10,000+ records across manufacturing, lab, and clinical systems

• Audit Efficiency: Reduced documentation review time by 40%

• Seamless Integration: Operated in validated environments without code changes

• Regulatory Alignment: Produced audit-ready artifacts accepted under FDA, EMA, and MHRA frameworks