eDHR software.

1The eDHR is the as-built product record.

An electronic device history record should prove that the physical device was built, inspected, labelled and released against the approved definition in effect for that unit or lot. It is not a scanned traveler, and it is not a folder assembled after production.

The approved definition describes what may be built; the eDHR records what was built. That distinction has to survive revisions, substitutions, rework, split lots, outsourced operations and serial-level variation. Seal turns the approved device master data into guided execution, so components, equipment, operators, measurements, inspections, labels, software, exceptions and release decisions accumulate around the actual serial or lot while the work happens. Unit-level products carry their own genealogy; true batch products share order-level evidence without copying it into thousands of records.

FDA’s Quality Management System Regulation, effective 2 February 2026, incorporates ISO 13485:2016 by reference.¹ The framework changed, but the operational need did not: the manufacturer must retain controlled evidence that production and acceptance followed the applicable specification and quality system.

For any serial or controlled lot, an authorised reviewer should be able to answer, from connected source records rather than a narrative assembled for an inspection, which revision and route governed the build; which components were installed, removed or scrapped; which people, equipment and software performed each operation; which measurements supported acceptance; which labels were printed and applied; which nonconformances and rework affected the unit; and who released it, on what evidence and where it shipped. Paradromics runs its brain-computer interface manufacturing travelers and quality records in Seal; its story reports 80% less operator paperwork and 90% less traveler review time for engineers.

1.1Why teams choose Seal for device history records

Device history is usually a paper traveler or a document-driven MES configuration, scanned or compiled after production and validated as a fixed system, so improving an inspection step needs its own change-control and regression-testing cycle. Seal holds the device master data as executable configuration on one platform with components, labels, nonconformance and release, and each tested, approved change creates a new revision. Each serial keeps the revision it was built to, and engineers can improve the build from real nonconformances without reopening the whole system.

2Device master data becomes executable behaviour.

Drawings and procedures remain controlled source documents, but production needs structured rules. A device configuration resolves the current bill of materials, routing, work instructions, tools and fixtures, equipment classes, software or firmware, inspection plans, labels and signatures. Effectivity can depend on date, site, line, market, model, revision or serial range, and Seal freezes the applicable configuration when execution begins. An engineering change identifies the open orders, inventory, training, inspection programmes, labels and released populations it affects before the new state takes effect.

ERP can remain authoritative for demand and the work-order reference. Seal creates or receives the GMP execution identity and the planned product, revision and quantity. Serial numbers can be assigned at order creation, at a controlled step or when the physical identifier is applied, and the system distinguishes reserved, built, accepted, rejected, scrapped, released and shipped states. Split and merge events preserve which evidence applies to which physical units, so a trace works in both directions: from a device to every input and decision, or from a component or process concern to every affected device.

3Components, tools and people are checked at the point of use.

Each issue or scan checks the part number, approved revision, supplier and internal lot, serial where applicable, status, expiry, quantity and eligibility for the active configuration. An alternate part needs an effective approved rule, not a free-text explanation. Actual consumption stays distinct from planned consumption, and scrap, returns, substitutions and partial use reconcile against the work order. A supplier nonconformance can then trace forward through subassemblies to finished serials without an exported ERP report.

The selected asset must be qualified for the operation and current for calibration, maintenance, setup and software state, and the operator must hold the effective training and practical qualification for the task. Tools and fixtures can carry their own serial identity, calibration range and usage count. If a torque tool later fails calibration, the record identifies every unit processed since its last acceptable condition and places that population into assessment.

4Assembly and inspection evidence enters at the operation.

Guided steps show only the effective instruction and the evidence it requires. Barcode scans, torque values, cure conditions, setup confirmations, photographs, machine results and witness signatures enter at the operation where they matter. Dependencies control sequence, and approved branches handle legitimate variation. A skipped operation, late entry, failed prerequisite or out-of-range value remains an exception, with the original value, correction, reason, user and time retained rather than overwritten.

Incoming, in-process and final inspection records keep the characteristic, method, instrument, unit or sample, specification, measured value, result and inspector. Machine-vision and tester output can remain authoritative in its source system while Seal receives the contextual result and a reference to the evidence. Sampling plans resolve from the effective configuration. A failed inspection identifies the exact unit or bounded lot and starts the approved nonconformance path; a retest and a resample are separate, justified events.

5Labels, UDI and firmware come from approved state.

Label content should come from controlled product, market, manufacturing, expiry and UDI data. Seal renders the approved template, verifies the printer and label stock, records the output identity and confirms application to the correct device or packaging level. A reprint keeps its reason and its relationship to the earlier output, and packaging and scrap events reconcile serial identities.

For connected or software-containing devices, the installed software or firmware, its configuration, checksum or cryptographic identity, the installation tool and the verification result belong in the as-built record. A note that software was loaded is not genealogy. Seal can check the approved version and capture the identity the device reports, so a patch can be traced from design approval through production effectivity to the installed units that need assessment.

6Rework and external processing stay attached to the device.

A nonconformance starts with the affected device, operation, characteristic, component, equipment and evidence attached, and containment identifies the physical population. Review decides between correction, rework, use-as-is where permitted, return or scrap. An approved rework instruction creates additional execution while preserving the original failed state, and re-inspection demonstrates the outcome. The completed record shows both the intended route and every authorised departure.

Sterilisation loads, special processes and contract operations may happen away from the assembly line, but their evidence must still resolve to the exact device population: shipment and custody, load composition, cycle identity, certificates, deviations, receipt and acceptance. Pending external evidence stays pending. Uploading a certificate does not silently release units.

7Release reviews a complete record, and the field closes the loop.

Review by exception brings forward missing steps, corrections, overrides, failed checks, open nonconformances, unreconciled components or labels, overdue equipment and pending external evidence, while the full record stays available. The disposition records the device population, evidence state, open conditions, decision, accountable role and signature meaning. Release changes the controlled state of the physical units; it does not merely complete a PDF.

After release, the serial or lot connects complaints, service, returns, adverse events and field actions to the original build evidence. A reported failure can expose the configuration, components, suppliers, equipment and inspection history, and find similar units. A component, process or software finding can trace forward to the installed population. Post-market evidence can open a CAPA or change without modifying the historical eDHR.

8Define the system boundaries, then prove one serial.

PLM may own design structures and engineering changes, ERP demand and financial inventory, testers and machines their acquisition, and specialist platforms serialisation or field service. Seal can own the effective manufacturing configuration, controlled execution, actual genealogy, inspections, exceptions and disposition. Each interface needs more than a field map: object identity, authoritative state, acknowledgement, duplicate handling, outage behaviour and reconciliation. A firmware value reported by a tester must resolve to the same device and approved software used by the route, and a component issue in ERP must not release a unit whose genealogy in Seal is incomplete. This design is part of validation, because it decides which system a reviewer trusts when values disagree or messages arrive late.

Start by running one representative device from component receipt through serial assignment, assembly, automated and manual inspection, a failed check, approved rework, UDI labelling, external processing, review and release. Then trace backward from the released serial and forward from a component lot, and rehearse a calibration failure, incorrect firmware, a label reprint, missing supplier evidence and a field complaint. The system is ready when each scenario identifies the exact population and reconstructs the decision without manual compilation.