Executive Summary: In today’s regulatory landscape, compliance and traceability are non-negotiable. Medical device, pharmaceutical, and life sciences manufacturers face mounting pressure to maintain accurate, audit-ready Device History Records (DHRs). Traditional paper-based or hybrid systems are no longer adequate. V5 Traceability by SG Systems Global delivers a transformative solution—migrating organizations from manual DHRs to fully compliant electronic Device History Records (eDHRs). This guide walks you through the full journey of how V5 supports digital transformation, regulatory compliance, and operational excellence—backed by real-world sample data.
What Is a Device History Record (DHR)?
A Device History Record is a complete compilation of production data for a specific batch or unit of a regulated product. It includes material usage, process parameters, quality checks, operator sign-offs, and equipment verification. A DHR proves that a product was manufactured in accordance with its specifications and complies with regulatory standards such as 21 CFR Part 820 and ISO 13485. In a recall or audit, the DHR is the manufacturer’s first line of defense.
“V5 gave us traceability, validation, and peace of mind—all in one system.”
— Regulatory Affairs Lead, Life Sciences Company
Why Manual DHRs Fail Modern Requirements
- ❌ Handwritten forms are susceptible to human error and missing data
- ⏱️ Paper records slow down QA review and batch release
- ⚠️ Inconsistencies across shifts and operators lead to quality drift
- 📁 Difficult to access during audits or recalls
- 💸 Costly document storage, scanning, and retrieval overhead
What Is an eDHR and Why It Matters
An electronic Device History Record (eDHR) is a fully digital system that captures every step of the manufacturing process in real time. Using V5 Traceability, manufacturers automate data collection from scales, barcode scanners, printers, and operators—eliminating the need for manual transcription. eDHRs ensure compliance with 21 CFR Part 11 by securing electronic records, e-signatures, audit trails, and role-based access. With eDHRs, QA can instantly review and release batches without sorting through paperwork.
“Batch release used to take 2 days. Now it’s under 2 hours—fully digital, no paper.”
— Production Manager, Sterile Packaging Facility
V5 Traceability in Action: Real-World eDHR Example
The V5 system automatically generated a complete eDHR for the production of a non-sterile bronchoscope pouch. This included:
- Batch metadata: Job number, batch ID, production time, operator ID, and location
- Line clearance audit: Conformance to ISO 13485 and 21 CFR Part 820 for cleanliness, labeling, component validation, and first article inspection
- Calibration audit: 12 instruments including HPLC, balances, and torque wrenches validated for compliance
- Material traceability: Every component (label, tray, zipper bag, etc.) tracked by supplier lot number, quantity, and usage timestamp
- Serialization: 38 unique serial numbers auto-generated and linked to individual assembly events
- Job-end QA: Automated pallet inspections, sterile load number validation, and equipment re-verification
Contact us to request a redacted eDHR report and see exactly how V5 performs in audit conditions.
Compliance with Global Regulations
V5 Traceability is engineered to support:
- 21 CFR Part 11: Electronic signatures, record security, and audit trails
- 21 CFR Part 820: Complete traceability, batch integrity, and document control
- ISO 13485: Calibration control, equipment validation, and DMR linkage
- EU MDR & Annex 11: Enforced workflow integrity and real-time data capture
Operational and Financial Benefits
Moving from manual DHR to eDHR with V5 delivers measurable ROI:
- ✅ Reduce QA labor by 50% with instant record access
- ✅ Accelerate batch release from days to hours
- ✅ Cut scrap and rework through in-process quality enforcement
- ✅ Eliminate deviations due to unauthorized edits or skipped checks
- ✅ Pass audits with confidence using real-time, tamper-proof logs
“We passed our ISO audit with zero findings thanks to V5’s real-time recordkeeping.”
— Quality Director, Medical Device Manufacturer
Implementation Timeline: Rapid & Validated
- Form digitization: Convert SOPs and batch records into digital templates
- Device integration: Connect to scales, barcode scanners, printers
- Validation: Pre-built IQ/OQ/PQ documentation packages included
- Go-live: First site live in under 30 days
- Scale-up: Deploy globally across facilities with standardized workflows
Built for the Floor: Why V5 Works in the Real World
V5 is not a theoretical MES—it’s production-proven. With thousands of records generated globally, V5 is already helping companies:
- Track and trace every component, tool, and action in production
- Validate compliance in regulated sectors: med devices, pharma, supplements
- Replace disconnected paper logs with unified, validated data flows
- Reduce risk while improving operational visibility
For a real-world walkthrough, request your eDHR sample today and see the data structures, logs, and validation reports we deliver.
About SG Systems Global
SG Systems Global develops traceability, MES, QMS, and WMS solutions specifically for process manufacturers in regulated industries. Explore our full solution suite for medical device manufacturers. V5 is the culmination of 20+ years of experience in delivering compliance, efficiency, and accountability at scale.
