Electronic Device History Record (eDHR) – Digital Traceability for ISO 13485 & FDA Compliance
An Electronic Device History Record (eDHR) is a mandatory digital record of each medical device unit produced. Required by ISO 13485 and FDA’s 21 CFR Part 820, the eDHR proves that every product has been manufactured and tested according to approved procedures. Without an accurate and traceable eDHR, your device is not compliant—and not marketable.
V5 from SG Systems Global automates the creation of Electronic Device History Records by capturing manufacturing data directly from the shop floor. Every operator step, equipment reading, and quality check is digitally enforced, timestamped, and stored—providing audit-ready documentation for every unit you release.
“Our eDHR process used to take days and multiple reviews. With V5, it’s live, paperless, and inspection-ready in real time.”
— Director of QA, Class II Device Manufacturer
What is Included in an eDHR?
A compliant eDHR must contain all the information proving a device was made according to its Device Master Record (DMR). Typical elements include:
- Device identifiers, serial numbers, and lot codes
- Raw material lot traceability
- Work instructions followed and signed off
- Operator credentials and timestamps
- Inspection results and test records
- Deviation and non-conformance reports
- Calibration records of critical equipment
- Final release and QA approvals
Each record must be complete, legible, securely stored, and readily retrievable—requirements that paper systems routinely fail to meet.
Why Switch from Paper DHRs to eDHRs?
Paper Device History Records are error-prone, difficult to manage, and expensive to maintain. Common issues include:
- Missing or illegible entries
- Unverified steps or skipped approvals
- No live visibility during production
- Slow review cycles and delayed release
- Vulnerabilities to tampering or damage
V5 replaces this fragile process with a secure, digital workflow that enforces compliance in real time—capturing data as it happens, not after the fact.
How V5 Automates the eDHR Process
The V5 platform integrates directly with operators, machines, and quality teams to build an eDHR as the device is made. Key capabilities include:
- Live production data capture with MES integration
- Role-based operator checklists and validation steps
- Automated link to equipment calibration records
- Escalation workflows for deviations and NCRs
- Electronic signatures and 4-eyes review logic
- Secure audit trail and PDF export on demand
Nothing is handwritten. Nothing is lost. Nothing is released without a full, verified, electronic Device History Record.
Built for ISO 13485 and FDA Readiness
V5 was engineered for medical device environments regulated under ISO 13485 and 21 CFR Part 820. It helps meet documentation, traceability, validation, and review control expectations with zero gaps:
- Digital enforcement of DMR instructions per device type
- Lot-to-unit traceability of components and subassemblies
- Secure access control and audit trail of all changes
- Timestamped signatures per 21 CFR Part 11 standards
Whether you produce single-use devices or high-value capital equipment, V5 creates bulletproof eDHRs that reduce review time and survive any audit.
Request a Sample eDHR
See what a real Electronic Device History Record looks like. Contact us to request a sample eDHR from V5. We’ll tailor it to your device class, regulatory scope, and documentation needs.
You’ll receive a real example showing:
- Live data capture tied to production steps
- Digital signatures and release approvals
- Deviations escalated into CAPA workflows
- Final QA sign-off and PDF archiving
V5 makes electronic Device History Records reliable, automated, and inspection-ready.
Frequently Asked Questions
What is an eDHR?
An eDHR (Electronic Device History Record) is the digital version of the Device History Record required by ISO 13485 and FDA 21 CFR Part 820. It documents how a medical device was manufactured and approved.
Is V5 compliant with ISO 13485 and FDA requirements?
Yes. V5 is used by regulated medical device companies to enforce documentation, traceability, and release controls in line with ISO 13485 and FDA expectations.
Can V5 integrate with our MES or ERP system?
Yes. V5 is built to integrate with leading MES, ERP, and QMS platforms for a connected compliance ecosystem.
