# Device History Record Software: FDA-Compliant DHR for Medical Device Manufacturing Every medical device that leaves your facility must have a Device History Record that demonstrates the device was manufactured in accordance with the Device Master Record. That is not a best practi... ## Device History Record Software: FDA-Compliant DHR for Medical Device Manufacturing Electronic DHR systems for medical device manufacturers — 21 CFR 820.184 compliant production traceability, component lot tracking, in-process and final inspection records, labeling verification, sterilization documentation, and full device genealogy from raw material receipt to finished goods release. FreedomDev builds DHR software that replaces paper traveler packets with validated digital records your quality team and FDA investigators can trust. --- ## Our Process 1. **DMR Mapping and Production Workflow Analysis (2-3 Weeks)** — We start with your Device Master Record — the production routing, bill of materials, inspection procedures, labeling specifications, and sterilization requirements for each device family. Every DHR data element required by 21 CFR 820.184 is mapped to the specific production step where it will be captured. We document the current paper-based DHR process, identify gaps between your current records and regulatory requirements, and design the electronic DHR workflow that enforces completeness at every step. Deliverable: a DHR data model that maps every required record element to a production step, operator role, data capture method (scan, manual entry, equipment integration), and acceptance criterion. This document becomes the functional specification for system development and the basis for OQ test protocols. 2. **System Architecture and Part 11 Controls Design (2-3 Weeks)** — The electronic DHR system architecture is designed to satisfy both the 820.184 DHR requirements and the Part 11 electronic records requirements simultaneously. Database schema design includes immutable audit trail tables with database-level triggers (not application-level logging), electronic signature infrastructure with cryptographic record binding, role-based access control matrices mapped to your organizational roles, and equipment integration interfaces for sterilization systems and inspection instruments. The architecture document specifies how each Part 11 requirement (11.10(a) through 11.10(k) for closed systems) is satisfied at the technical level. This document is reviewed by your quality and IT teams before development begins and becomes a controlled document in your quality system. 3. **Development, Unit Testing, and Equipment Integration (6-10 Weeks)** — Core system development proceeds in phases aligned with your production routing: component receiving and incoming inspection, production workstation data capture, in-process and final inspection, labeling and packaging, sterilization (if applicable), and batch release workflow. Each module is unit tested and integration tested against simulated production data before connecting to production equipment. Equipment integration — barcode scanners, measurement instruments, sterilization controllers, label printers — is validated at the interface level to confirm data integrity between the equipment output and the DHR record. For facilities with multiple production lines or multiple device families, the system is configured per the DMR for each product and tested with production-representative data for each configuration. 4. **IQ/OQ/PQ Validation and 21 CFR Part 11 Verification (3-4 Weeks)** — The system undergoes formal computer system validation per GAMP 5 guidelines. Installation Qualification confirms the system is installed according to the architecture specification — correct server configuration, database version, network connectivity, backup procedures, and disaster recovery. Operational Qualification executes test protocols that verify every functional requirement: DHR data capture at each workstation, inspection enforcement logic, electronic signature controls, audit trail immutability, component lot traceability, labeling verification, sterilization parameter capture, and batch release workflow. Performance Qualification runs the system under production-representative conditions — actual operators, actual devices, actual production volumes — to confirm the system performs as intended in the real manufacturing environment. All validation protocols, test results, and deviation reports are compiled into a validation summary report for your quality system records. 5. **Production Deployment, Parallel Running, and Ongoing Support (2-4 Weeks + Ongoing)** — The electronic DHR system runs in parallel with your existing paper DHR process for a defined validation period — typically 2 to 4 weeks or a minimum number of production lots, whichever is greater. During parallel running, both the paper DHR and electronic DHR are completed for every lot. Quality compares the two records to confirm the electronic system captures every data element the paper system captures, plus the additional automated checks and traceability features. Once parallel running demonstrates equivalence, your quality team authorizes the transition to electronic-only DHR through your change control process. Post-deployment support includes system monitoring, periodic review of audit trail integrity, user account management, DMR change integration (when your production routing or inspection requirements change), and regulatory update assessment when FDA publishes new guidance affecting DHR or Part 11 requirements. --- ## Frequently Asked Questions ### What does 21 CFR 820.184 require in a Device History Record? 21 CFR 820.184 requires that each manufacturer maintain a Device History Record for each batch, lot, or unit of finished devices. The DHR must include or refer to the location of the following information: the dates of manufacture; the quantity manufactured; the quantity released for distribution; the acceptance records which demonstrate the device is manufactured in accordance with the Device Master Record (DMR); the primary identification label and labeling used for each production unit; and any unique device identifier (UDI) or universal product code (UPC), as well as any other device identification and control numbers used. For sterilized devices, the DHR must also reference sterilization process records. The key phrase is 'demonstrate the device is manufactured in accordance with the DMR' — the DHR is the evidence that your production process was followed as designed for that specific lot. If any required record is missing, that lot cannot be demonstrated as compliant, and FDA treats the devices as adulterated under Section 501(h) of the FD&C Act. ### How does electronic DHR software satisfy 21 CFR Part 11 requirements? An electronic DHR system must comply with 21 CFR Part 11 because it creates, modifies, and maintains electronic records required by a predicate rule (21 CFR Part 820, the Quality System Regulation). Part 11 compliance requires: validated systems with audit trails that are computer-generated, time-stamped, and record operator identity, action taken, previous value, new value, and reason for change; electronic signatures with two-component authentication (user ID plus password or biometric plus knowledge factor) that are legally binding and linked to their respective records; authority checks that restrict system access and signing authority to authorized personnel; and record protection that ensures accurate retrieval throughout the retention period. Our DHR systems implement these controls at the database level — audit trails use immutable append-only tables with database triggers that cannot be circumvented by application-level users, including system administrators. Electronic signatures are cryptographically hashed with the record content so any post-signature modification is detectable. The system is validated per GAMP 5 with IQ/OQ/PQ protocols that trace every requirement to a test case. ### Can the DHR system integrate with our existing ERP and sterilization equipment? Yes. Electronic DHR systems that operate in isolation from your ERP and production equipment miss the primary benefit: eliminating manual data entry and transcription errors. We build integration interfaces to ERP systems (SAP, Oracle, Epicor, Infor) for bill of materials data, production order management, and inventory lot tracking. For sterilization equipment, we integrate directly with EtO chamber controllers, autoclave PLCs, gamma irradiation dosimetry systems, and e-beam equipment to capture cycle parameters — temperature, pressure, gas concentration, exposure time, biological indicator results — directly from the equipment without manual transcription. For inspection instruments (CMMs, vision systems, hardness testers, dimensional gauges), we build data collection interfaces that capture measurement values electronically. Each equipment integration is validated as part of the overall system IQ/OQ/PQ, with test protocols that verify data integrity at the interface boundary. The integration architecture uses an abstraction layer so that equipment can be replaced or upgraded without rebuilding the entire DHR system. ### How long does implementation take for a typical Class II or Class III device manufacturer? For a single production line manufacturing one device family, a complete electronic DHR implementation — from DMR mapping through validated production deployment — takes 15 to 24 weeks. The breakdown is approximately: DMR mapping and workflow analysis (2 to 3 weeks), system architecture and Part 11 controls design (2 to 3 weeks), development and equipment integration (6 to 10 weeks), IQ/OQ/PQ validation (3 to 4 weeks), and parallel running with production cutover (2 to 4 weeks). Multi-line facilities or manufacturers with multiple device families require additional time for each product configuration — typically 3 to 6 additional weeks per production line after the first. Class III devices with complex sterilization requirements, extensive in-process testing, or multi-stage assembly processes fall toward the longer end of each range. The single largest variable is equipment integration: facilities with modern networked equipment and accessible data interfaces integrate faster than facilities with legacy standalone equipment that requires custom interface development. ### What happens during an FDA inspection when we have an electronic DHR system? FDA investigators inspect electronic DHR systems under two frameworks simultaneously: 21 CFR 820.184 (DHR content requirements) and 21 CFR Part 11 (electronic records and electronic signatures). For 820.184, the investigator will request DHRs for specific production lots — typically selected from your distribution records or complaint files — and verify that each required element is present: dates of manufacture, quantities, acceptance records, labeling, and identification numbers. With an electronic system, you retrieve the complete DHR in seconds and present it on screen or as a printed report. The investigator will also test traceability: given a device serial number from a complaint, can you trace back to every component lot, every inspection result, and every operator who touched that device? For Part 11, the investigator will evaluate your audit trail (request a record modification and verify the trail captures before/after values, timestamp, operator, and reason for change), test electronic signature controls (attempt to sign without proper credentials, verify signature manifestation includes name, date, and meaning), and review your computer system validation documentation (validation plan, protocols, test results, traceability matrix). A well-implemented electronic DHR system makes FDA inspections faster and lower risk because every requested record is immediately available, complete, and demonstrably tamper-evident. ### How does the system handle nonconforming product and production deviations? When an in-process inspection fails, a measurement falls outside specification, or a process parameter deviates from the validated range, the electronic DHR system creates a nonconformance record automatically linked to the affected production lot, the specific production step, and the specific data point that triggered the deviation. The production record is placed on hold — the lot cannot advance to the next production step, and batch release is blocked until the nonconformance is dispositioned. Disposition options follow your quality system procedures: use as is (with documented justification and appropriate approval authority), rework (with a rework procedure linked back to the DMR), return to supplier (for component-level nonconformances), or scrap. Each disposition requires electronic signature from the authorized role defined in your quality system. The nonconformance record, investigation findings, root cause analysis, corrective actions, and disposition decision all become part of the DHR for that lot. This satisfies 21 CFR 820.90 (nonconforming product) and ensures that every deviation is documented, investigated, and resolved before product is released — without relying on operators to remember to fill out a paper form or quality engineers to manually cross-reference deviation logs against production records. --- **Canonical URL**: https://freedomdev.com/solutions/medical-device-dhr-software _Last updated: 2026-05-12_