OpsTrakker GMP Solutions
Contact us for help!
If you would like to discuss how your business can benefit from OpsTrakker solutions, please contact us.
Digitize Medical Device Manufacturing with OpsTrakker eDHR Software
Paper-based Device History Records create unnecessary complexity in medical device manufacturing. Handwritten documentation, manual data entry, incomplete records, and lengthy review processes can impact production efficiency, product traceability, and quality.
OpsTrakker Electronic Device History Record (eDHR) software replaces paper-based manufacturing documentation with controlled digital workflows. By guiding operators through manufacturing and assembly activities, capturing production data in real time, and maintaining traceable electronic records, OpsTrakker helps medical device manufacturers improve operational efficiency, reduce documentation errors, and support regulatory compliance.
Built on the OpsTrakker Digital Enablement Platform, eDHR can operate as a standalone solution or complement existing Manufacturing Execution Systems (MES), ERP, QMS, and other enterprise applications.
A Flexible eDHR Solution for Medical Device Manufacturing
Medical device manufacturers operate in highly regulated environments where documentation, traceability, and quality are essential. Traditional paper-based Device History Records can require extensive manual effort to complete, review, approve, and archive.
OpsTrakker eDHR enables manufacturers to digitize production and quality documentation without introducing unnecessary complexity. Its configurable workflow engine supports guided manufacturing execution, electronic data capture, operator verification, and review-by-exception.
Whether manufacturing individual devices, serialized products, or production lots, OpsTrakker provides the flexibility to digitize device manufacturing records while accommodating different production environments and operational requirements.
OpsTrakker eDHR Module
OpsTrakker eDHR helps manufacturers digitize and manage the activities and documentation associated with medical device production.
From component verification and assembly instructions to in-process inspections, equipment records, packaging activities, and final approvals, OpsTrakker enables organizations to capture critical manufacturing information electronically at the point of execution.
Solution features
- Electronic Device History Records (eDHR)
- Guided Manufacturing and Assembly Workflows
- Activity Sequence Enforcement
- Electronic Signatures and Audit Trails
- Review-by-Exception
- Barcode and QR Code Data Entry
- Component, Lot, and Serial Number Traceability
- In-Process Quality Inspections and Verifications
- Electronic Work Instructions and Checklists
- Configurable Data Validation and Required Fields
- Equipment and Material Status Integration
- Integration with ERP, MES, QMS, and Other Systems
- Mobile-Ready Digital Workflows
Problems solved
- Paper-based Device History Records and manufacturing documentation
- Incomplete, inaccurate, or illegible production records
- Manual transcription and duplicate data entry
- Missing signatures and documentation errors
- Lengthy Device History Record review and approval cycles
- Difficulty tracing components, materials, and manufacturing activities
- Disconnected manufacturing and quality information
- Time-consuming record retrieval during audits and investigations
Benefits delivered
- Eliminate Paper-Based Device History Records
- Improve Manufacturing Traceability
- Support FDA 21 CFR Part 11 and Applicable QMSR Requirements
- Improve Right First Time Execution
- Reduce Documentation Errors
- Accelerate Record Review with Review-by-Exception
- Improve Operator Efficiency and Productivity
- Standardize Manufacturing Processes Across Facilities
- Enable Real-Time Production Visibility
- Create Structured Digital Data for Analytics and AI
- Support Audit Readiness and Data Integrity
Go Beyond Device History Records with OpsTrakker
OpsTrakker is designed to digitize far more than Device History Records. As a configurable Digital Enablement Platform, OpsTrakker supports electronic logbooks, forms, checklists, equipment records, cleaning activities, work instructions, inspections, material tracking, weigh and dispense, and virtually any paper-based manufacturing workflow.
Manufacturers can begin with eDHR and expand digitalization across production, quality, maintenance, and other operational functions using a unified platform.
From paper-based Device History Records to a fully connected manufacturing environment, OpsTrakker helps organizations advance their digital transformation at their own pace.
Ready to Eliminate Paper Device History Records?
Discover how OpsTrakker eDHR can help your organization digitize medical device manufacturing, improve traceability, and streamline production documentation.
Contact us to schedule a demonstration.
Frequently Asked Questions
An Electronic Device History Record (eDHR) is a digital record of the manufacturing activities, materials, inspections, verifications, and approvals associated with the production of a medical device or device lot. eDHR software replaces paper-based documentation with structured electronic records that improve traceability, data integrity, and manufacturing visibility.
eDHR software enables medical device manufacturers to electronically execute, document, and review manufacturing activities. OpsTrakker eDHR provides configurable digital workflows that guide operators through production processes while capturing manufacturing data, electronic signatures, timestamps, and quality information.
eDHR software replaces handwritten manufacturing records with guided digital workflows. Instead of completing paper forms, operators capture production information electronically at the point of execution. OpsTrakker helps enforce required data entry, maintain electronic records, and streamline manufacturing documentation and review.
Electronic Device History Records (eDHR) focus on documenting medical device manufacturing activities, including assembly, component traceability, inspections, and device-specific production history. Electronic Batch Records (EBR) typically focus on the execution and documentation of batch manufacturing processes. OpsTrakker supports both through configurable digital workflows tailored to different manufacturing requirements.
Yes. eDHR software can support applicable electronic record, electronic signature, traceability, and documentation requirements. OpsTrakker provides capabilities such as electronic signatures, audit trails, user access controls, and controlled workflows to help manufacturers meet relevant FDA 21 CFR Part 11 and ISO 13485 requirements. Compliance also depends on appropriate implementation, validation, and organizational procedures.
An eDHR can capture component and material information, serial and lot numbers, assembly activities, equipment details, process measurements, inspection results, operator actions, timestamps, electronic signatures, exceptions, and production approvals. OpsTrakker enables manufacturers to configure digital records around their specific device manufacturing processes.
Yes. OpsTrakker is designed to integrate digital manufacturing workflows with existing enterprise systems, including MES, ERP, QMS, and other manufacturing applications. OpsTrakker can also operate as a standalone Digital Enablement Platform, allowing manufacturers to manage electronic Device History Records independently of other enterprise systems.
eDHR software improves traceability by electronically linking manufacturing activities with relevant materials, components, equipment, operators, inspections, and production records. OpsTrakker helps manufacturers maintain structured, traceable information throughout device manufacturing, making it easier to retrieve records and investigate manufacturing issues.
Review-by-exception allows quality personnel to focus on records or activities that require additional attention, such as missing information, failed checks, deviations, or out-of-range values. OpsTrakker supports review-by-exception to help reduce manual review effort and improve the efficiency of manufacturing record approval processes.
Yes. OpsTrakker eDHR can operate as a standalone digital manufacturing solution or complement an existing MES. Its configurable workflows enable manufacturers to digitize device production, assembly, quality inspections, and manufacturing documentation without requiring a traditional MES deployment.
Yes. Electronic Device History Record solutions can support manufacturing environments where production records are associated with individual serial numbers, batches, or lots. OpsTrakker's configurable workflows can be adapted to capture the appropriate manufacturing and traceability information for different production processes.
eDHR software eliminates paper-based manufacturing documentation by capturing production activities electronically. OpsTrakker goes beyond Device History Records, enabling manufacturers to digitize forms, checklists, equipment logbooks, work instructions, inspections, and other paper-based workflows across the facility.
OpsTrakker eDHR is an Electronic Device History Record solution built on the OpsTrakker Digital Enablement Platform. It enables medical device manufacturers to replace paper-based production records with controlled digital workflows, improve manufacturing traceability, streamline record review, and support regulated manufacturing operations.