eDHR
Electronic Device History Record System
The Mission
Generate Device History Records digitally and on-the-fly while following and confirming work-instructions for MedTech equipment.
Overview
eDHR was a self-initiated continuous improvement project to digitise Device History Records in a regulated environment. I identified issues with paper-based records, including occasional incomplete data, which posed an audit risk. The solution became a configurable digital workflow engine, supporting multiple products and manufacturing flows while enforcing sequencing, validation and traceability.
Replaced manual Device History Records with validated, step-based digital workflows
Eliminated common documentation errors through enforced sequencing and validation
Delivered audit-ready electronic traceability approved by quality and regulatory teams
Achieved strong operator adoption through collaborative design
01 // Discovery & Design
// Discovery
Shadowed shop-floor users to understand issues with paper-based records
// Key Decisions
The system had to be configurable and useable for other products; the 'Next' and 'Back' buttons had to be displayed in random positions to avoid operator fatigue and automatic clicking
// Trade-offs
Developed in Excel VBA to leverage existing infrastructure, IT-approval constraints and user familiarity
🛠️ One thing we changed after launch
Integrated with a dedicated line printer, as compliance meant all records had to be physically signed and stored
02 // Technical Execution
// Tech Stack
Excel VBA, integration with IFS to automatically upload the eDHRs
// Implementation
Master template controlled by IT QA; product-specific master copies controlled by Manufacturing Engineers; product working files in a networked location
💡 One thing I would do different now
Implement stronger version control and structured logging to improve long-term maintainability across multiple product configurations
03 // Ownership
// Team
Me, myself and I. I worked closely with Production, Engineering, shop floor managers, QA, IT and operators to ensure usability, trust and adoption
// Timeline
Developed over a few months, as it was not my main focus of work
// Ownership
I owned the whole eDHR application and IT owned the ERP-connector
❤️ The thing I enjoyed the most
Designing something practical that operators trusted daily and that measurably reduced audit risk