Building a Compliant EHR and Digital Health QMS

A HealthSec Alliance™ Case Study

Client: Global Pharmaceutical and Digital Health Organization

Challenge

The client aimed to modernize its digital health infrastructure and unify compliance, data integrity, and patient safety across global operations. Oversight of EHR and Software as a Medical Device (SaMD) systems was fragmented across subsidiaries, creating inconsistent validation and duplicated compliance work.

They needed a validated Quality Management System (QMS) to manage the full lifecycle of digital health and EHR products while ensuring worldwide regulatory and privacy compliance. Key objectives included: 

• Achieve audit-ready compliance across EHR and digital health systems

• Integrate privacy, cybersecurity, and lifecycle risk management

• Centralize quality and data oversight under one QMS

• Build a scalable, globally aligned compliance framework

Solution

The HealthSec Alliance™ designed, validated, and deployed a Digital QMS for EHR-integrated pharmaceutical systems. The project unified software validation, cybersecurity, and compliance management under one framework, embedding Zero Trust and privacy-by-design controls across clinical and manufacturing data flows.

Core activities:

• Built a validated Digital QMS with EHR, SaMD, and pharmacovigilance workflows.

• Integrated cybersecurity, audit automation, and anchored data integrity controls.

• Mapped compliance to FDA 21 CFR Part 11, EU MDR/IVDR, ISO 13485, ISO 14971, and IEC 62304.

• Unified HIPAA, GDPR, HITECH, and U.S. state privacy requirements under one data-protection framework.

Technical & Regulatory Framework

• Quality & Risk Standards: ISO 13485:2016, ISO 14971:2019, IEC 62304, IEC 62366, ISO/IEC/IEEE 29148

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

• Privacy & Security: HIPAA, HITECH, GDPR, MHMD (WA), CT SB3, TX HB300, NY HIPAA

Outcomes & Impact

• Audit-Ready Compliance: Inspection-ready documentation and full traceability across EHR systems.

• Centralized Governance: Manufacturer, data, and quality oversight unified under one QMS.

• Accelerated Innovation: Standardized validation reduced release friction and improved agility.

• Lifecycle Assurance: Continuous risk and cybersecurity monitoring embedded throughout operations.