electronic device history record

An electronic device history record (often abbreviated eDHR) is a digitally maintained, unit-specific record that documents how a particular product or serialized device was manufactured, inspected, tested, and released. It is the electronic counterpart of a paper device history record and is commonly used in regulated manufacturing environments such as medical devices, pharmaceuticals, and other life sciences and high-reliability industries.

What an electronic device history record includes

An electronic device history record commonly includes:

• Identification of the specific unit or lot (serial numbers, batch/lot numbers)
• The bill of materials actually used, including component and material lot numbers
• Manufacturing steps performed, including dates, times, equipment, and locations
• Operator or system IDs associated with each executed step
• Process parameters and key production data captured from MES, PLCs, and other OT/IT systems
• In-process and final inspection results, test data, and pass/fail decisions
• Recorded deviations, nonconformances, rework, and associated approvals
• Electronic signatures and approvals for production, quality review, and release

The focus is on the actual history of a specific unit or lot, not the intended instructions or specifications.

How it appears in manufacturing systems

In practice, an electronic device history record is assembled from multiple systems:

• MES and electronic batch record systems capture execution data for each operation and associate it to the relevant unit or lot.
• PLCs and automation systems provide time-stamped process data and equipment status that may be linked into the record.
• LIMS, quality, and test systems contribute test results, inspections, and quality decisions.
• ERP and inventory systems provide material genealogy, work orders, and lot/serial assignments.

The eDHR is often presented as a consolidated view or report that can be queried by serial number, lot, work order, or date range for traceability and audit purposes.

What an electronic device history record is not

• It is not a device master record or master recipe. Those define how a product should be built; the eDHR documents how it was actually built.
• It is not limited to a single system log. It typically aggregates data across MES, PLCs, ERP, quality, and laboratory systems.
• It is not a generic production report. It is specific to an individual serialized unit or a defined lot/batch.

Relationship to MES and PLCs

Electronic device history records rely on data captured at different layers of the manufacturing stack:

• PLCs and other control devices collect real-time machine and process values but do not, by themselves, structure these into a complete device history.
• MES and related execution systems orchestrate work orders, enforce workflows, collect operator input, and link equipment and material data, forming the core of the eDHR.

The eDHR is therefore an outcome of integrated OT and IT systems, rather than a single standalone application.

Common confusion

• Electronic device history record vs. electronic batch record (eBR): An eDHR is usually associated with discrete or serialized units (for example, medical devices), while an eBR often refers to batch or process manufacturing records. In practice, organizations may use the terms differently, but both serve a similar purpose of documenting actual production history electronically.
• Electronic device history record vs. device master record (DMR) or product specification: The DMR or specification defines requirements, procedures, and materials. The eDHR documents actual execution against those requirements.