eDHR Software

This topic is part of the SG Systems Global medical device, pharma packaging & regulated manufacturing documentation glossary.

Updated December 2025 • eDHR software, electronic device history record, DHR software, DMR control, UDI & labelling, ISO 13485, ISO 14971, QMSR, MES/QMS integration, genealogy & complaints • Medical Devices, IVD, Combination Products, Pharma & Biologics, High-Risk Consumables

eDHR software is not just “electronic batch record for devices”. It’s the layer of your stack that proves—for every finished device—exactly which materials, processes, inspections, labels, software versions and people were involved, and shows that each step followed an approved Device Master Record (DMR). In an ISO 13485 / QMSR world, an electronic device history record (eDHR) is the evidence that you actually built what your procedures describe, not a PDF tidy-up after the fact.

This hub page explains what “real” eDHR software looks like: how DMRs, work instructions, MES execution, machine data, in-process checks, UDI & labelling, genealogy and complaints/NC/CAPA all feed into a single device history record. It ties together the SG Systems Global glossary topics that sit under med-device documentation and shows how V5 can implement eDHR without turning every engineer into a part-time document wrangler.

“If your eDHR is mostly scanned paper, disconnected from presses, testers and lab systems, it’s not eDHR software—it’s an expensive filing cabinet with Wi-Fi.”

1) eDHR software stack — how the modules fit together

The table below groups key capabilities into layers of an eDHR software stack—from design & DMR through execution, tests, UDI, genealogy, complaints and governance:

2) What eDHR software actually does

An electronic device history record is the accumulation of all records that demonstrate a particular device (or lot of devices) was manufactured according to its DMR and regulatory expectations. eDHR software is the set of modules that:

• Interprets the DMR and work instructions into executable routes and checklists.
• Collects execution data from operators, machines, testers, lab systems and labelers as work is actually performed.
• Ensures materials, equipment and people are qualified and in the right state when they touch the product.
• Assembles a complete, reviewable record that can stand on its own during inspections, audits and investigations.

It is not a document repository, and it’s not only a MES. eDHR software sits at the intersection of QMS (requirements), MES (execution) and data integrity (records), with device-specific concepts like UDI, DMR, DHR and QMSR baked in.

3) eDHR vs eBR vs MES-only — why devices are different

Batch-driven industries often start with electronic batch record (eBR) concepts and try to apply them directly to devices. That only partly works:

• eBR. Focuses on batch-level manufacturing documentation, often around process parameters, materials and tests for a bulk product.
• eDHR. Adds device-specific context: UDI, serial numbers, DMR-driven routing, device-level genealogy, device-specific labelling and post-market linkages.
• MES-only. Tracks operations and sometimes materials, but doesn’t guarantee alignment with DMR or regulatory documentation requirements.

True eDHR software uses MES as its execution engine but enforces DMR structures, captures device-level traceability and integrates with QMS so that events in production are directly usable in NC/CAPA and risk management workflows.

4) DMR & design control — feeding eDHR from the right source

An accurate eDHR depends on a well-structured DMR. In practice, that means:

• Clear DMR content. The DMR must define components, drawings, specifications, equipment, software, labelling and packaging required to build the device.
• Linkage to DHF & risk. The Design History File (DHF) and ISO 14971 risk analyses explain why those DMR elements matter.
• Structured routing. The DMR’s process steps become MES routes and operations, via Routing & Operation Sequencing.
• Version control. Document and configuration control—under Document Control—ensure that eDHR software always knows which DMR version was in effect for a given lot or device.

When DMRs are ambiguous or inconsistent, eDHR implementations either become over-complicated or leave gaps that inspectors find quickly: missing inspections, unlabeled risks, undocumented equipment or software versions.

5) Execution & routing — what eDHR software must capture on the shop floor

On the shop floor, eDHR software turns DMRs into execution workflows. That involves:

• Digital job travelers. Job Traveler & Digital Routing ensures every part or lot follows the correct steps, in the right order, with context-sensitive work instructions.
• Equipment & tooling state. Records which moulds, fixtures, assembly stations, test rigs and software builds were used at each operation, and whether they were within calibration and maintenance windows.
• Operator identity & training. Users log in individually; eDHR software can check that they are trained/authorised for the operations they perform.
• In-process decisions. Pass/fail results, rework decisions, scrap coding and conditional branching are captured in structured form, not free-text notes.

Without this execution layer, an eDHR may know what was supposed to happen but not what actually did, which is exactly the gap investigators probe when something goes wrong.

6) Materials & component lots — device genealogy starts here

Because devices often use long supply chains and specialised components, eDHR software must be precise about materials:

• Material identity. Material Identity Confirmation ensures the right part numbers, revisions and suppliers are used.
• Lot assignment. Material Lot Assignment captures which lots were picked and consumed in each build.
• Supplier qualification & COAs. Supplier Quality Management (SQM) and Supplier Verification of COAs ensure the DHR can show why a component lot was acceptable.
• Alternate components. When approved alternates are used, eDHR software must record this explicitly and ensure equivalence is documented.

The result is a device genealogy that can answer: “Which component lots and suppliers are common across these complaint devices?” without manual detective work.

7) Test, QC & lab — closing the loop on evidence

Devices are heavily test-driven. eDHR software must integrate test and lab data instead of treating them as external attachments:

• In-process & final tests. Tests & Laboratory Analyses Review captures pass/fail, measured values, limits and who performed the test.
• LIMS integration. Interfaces with LIMS tie device-level tests to sample IDs and methods.
• Calibration status. Asset Calibration Status shows that test equipment was in calibration at the time of measurement.
• Release decisions. DHRs link test outcomes to batch or serial-level release/hold decisions by QA.

This is the difference between an eDHR that says “tested per SOP” and one that can show actual measured values, methods, acceptance criteria and equipment states for any inspection.

8) UDI, labels & packaging — eDHR as the truth for what left the plant

In med-device and related fields, label content and UDI data are core parts of the device itself. eDHR software must ensure that:

• UDI data is correct. UDI elements (DI, PI) are applied correctly at unit, case and pallet levels.
• Label copy matches registration. Label Copy & Regulatory Statement Control ensures text, logos, symbols and claims align with the DMR and registrations.
• Barcodes are verified. Label Verification & UDI Checks confirm that printed barcodes are readable and encoded correctly.
• Packaging configuration is recorded. The DHR includes what pack types, counts, IFUs and accessories each device or lot shipped with.

From a software standpoint, that means injection of label and UDI events into the same genealogy engine that tracks materials and process steps—so you can reconcile what was built with what was labelled and shipped.

9) Genealogy, complaints & NC/CAPA — why eDHR software really matters

The real test of eDHR software isn’t during go-live; it’s during complaints, vigilance and recalls. Then you need to be able to:

• Trace a device or serial number back to every relevant DHR entry—materials, processes, tests, labels, rework, deviations.
• Find all devices that share a suspect component, process deviation or test anomaly.
• Support investigations, risk re-assessments and regulatory reports with concrete, attributable evidence.

That’s where integration with:

• Device History Record (DHR),
• Deviation / Nonconformance (NC) and CAPA,
• and the Complaints, Recalls & Post-Market Surveillance Hub

becomes critical. eDHR software should make it normal—not heroic—to answer “What changed?” and “Who else is affected?” when adverse events are reported.

10) How V5 implements eDHR software

V5 eDHR software uses the same platform you use for eBMR, traceability and QMS, with med-device concepts switched on:

• V5 MES. The V5 MES layer:
  • Executes DMR-driven routes and work instructions, capturing operator actions, equipment, parameters and in-process results.
  • Integrates with machines, testers and labelers to collect real-time data into the DHR.
  • Handles rework and reinspection paths under control, ensuring they show up correctly in genealogy.
• V5 QMS. The V5 QMS layer:
  • Manages DMR, DHF and procedure documents, and ensures changes go through controlled approval.
  • Receives NC, CAPA and complaint records linked to specific DHR instances and genealogy.
  • Supports ISO 13485, ISO 14971 and QMSR-aligned workflows and management reviews.
• V5 WMS. The V5 WMS layer:
  • Handles material and component lot management, kitting and line staging for device builds.
  • Tracks finished devices, cases and pallets, and provides the shipping linkage in genealogy.
• V5 Connect API. The V5 Connect API:
  • Integrates existing testers, lab systems, PLCs, robots and labellers into the eDHR data stream.
  • Feeds regulatory reporting tools and BI dashboards with DHR data without duplicated data entry.
• V5 Solution Overview. The overall architecture—including device-focused examples—is described in the V5 Solution Overview.

11) KPIs that show your eDHR software is doing its job

• DHR completeness. % of released devices/lots with fully complete electronic DHRs (no missing signatures, tests or attachments).
• DHR query time. Minutes needed to retrieve and review a full DHR for an inspector or investigation.
• Record error rate. Number of documentation-related NCs (e.g. missing entries, illegible scans, misfiled records) per quarter.
• Change impact traceability. Ability to list all devices/lots affected by a given change in DMR, process or supplier component.
• Complaint traceability. % of complaints where root cause analysis is supported by specific DHR evidence, not just assumptions.
• Paper usage. Reduction in paper travelers, manual checklists and scanned PDFs over time as eDHR coverage expands.

12) Common pitfalls when implementing eDHR software

• “Scan and store” mentality. Simply scanning paper travelers into a repository and calling it eDHR, without structuring data for search or analysis.
• Ignoring integration. Leaving testers, PLCs, labelers and WMS out of scope, so critical evidence remains on islands.
• Overcomplicating forms. Designing DHR screens that mirror legacy forms instead of streamlining to what’s needed for compliance and risk.
• No DMR alignment. Implementing eDHR software without first cleaning up DMRs, leading to mismatches between design and execution.
• QMS disconnect. eDHR lives in one system; NC/CAPA and risk live in another; links are manual and fragile.

13) Quick-start checklist for an eDHR software roadmap

• Choose one representative device family (risk-relevant, not trivial) and map its current paper/device history record process.
• Review the DMR for that family: is it clear, current, and suitable for driving routes and checks in MES?
• Identify core data sources: MES (or equivalent), testers, lab systems, labelers, WMS, QMS. Document what each holds.
• Implement digital job travelers and basic DHR capture in V5 MES for that product family.
• Integrate at least tests, component lots and labels into the DHR, then run a mock complaint investigation using only the eDHR.
• Extend coverage stepwise: more operations, more testers, more product codes—while tying NC/CAPA and risk reviews into the DHR data model.

14) eDHR Software FAQ

Q1. Do we need both eBMR and eDHR software?
If you manufacture both drugs and devices—or drug-device combinations—you almost certainly need both concepts. The underlying platform can be the same (V5), but the data structures and regulatory expectations differ. eBMR focuses on process batches; eDHR focuses on device-level genealogy, DMR alignment and UDI-aware records.

Q2. Can we implement eDHR software without changing our QMS?
You can start capturing data, but to fully satisfy ISO 13485, ISO 14971 and QMSR expectations, QMS and eDHR must be aligned: DMRs, SOPs and risk assessments need to match what eDHR software executes and records. Often the first step is harmonising document control and DMR structures so software has a clean source of truth.

Q3. How does eDHR software support FDA inspections and NB audits?
Good eDHR software makes it trivial to retrieve a complete DHR, showing clearly which DMR version was used, what materials and equipment were involved, what tests were run (with results), what labels were applied and which deviations were handled. That shortens inspection time and increases confidence that your system is under control.

Q4. Do we need serial-level eDHR for every device?
Not always. Some devices and packaging operations can be managed at lot or batch level, especially for low-risk, high-volume consumables. Others—particularly implantables, high-risk devices and UDI-critical products—require serial-level detail. A good platform lets you mix lot-level and serial-level eDHR where appropriate.

Q5. How can we measure the success of our eDHR implementation?
Look at inspection outcomes, the effort required to prepare for audits, the speed and depth of complaint investigations, the rate of documentation-related NCs and the amount of manual transcription still required. If those trends are improving, your eDHR software is doing its job; if not, you may have simply digitised old pain points instead of fixing them.

Related Reading
• Device Records & Docs: Device History Record (DHR) | Device Master Record (DMR) | Design History File (DHF) | Define Batch Manufacturing Record
• Regulatory & QMS: ISO 13485 | ISO 14971 | QMSR | Quality Management System (QMS) | Data Integrity
• Execution & Lab: MES – Manufacturing Execution System | Tests & Laboratory Analyses Review | LIMS | Asset Calibration Status
• Complaints & Risk: Deviation / Nonconformance | CAPA | Complaints, Recalls & Post-Market Surveillance Hub
• V5 Products: V5 Solution Overview | V5 MES | V5 QMS | V5 WMS | V5 Connect API