January 2026 — Global — In medical device manufacturing, “paper travelers” fail for one reason: they invite reconstruction. They create a record that looks complete after the fact, but collapses under inspection pressure when an investigator asks for proof of execution timing, authority, and scope. An audit-ready eDHR is not a prettier traveler. It is a control system that produces the device history record as an output of execution: identity locked to work, acceptance tied to evidence, deviations governed in real time, and an audit trail that stands without narrative repair. This is the practical difference between “we have documentation” and “we can prove control.”
This matters because inspectors do not audit intent. They audit the credibility of the record: is the history contemporaneous, does it map to the actual unit/lot, and can the firm retrieve evidence without hunting through shared drives and binders? In device terms, the question is whether the Device History Record (DHR) can be produced as a coherent evidence pack that links build steps to acceptance activities, nonconformances to containment, and release decisions to authority. That posture depends on data integrity and identity discipline: controlled actions, controlled signatures, and records that resist quiet edits through electronic signatures and governed retention via record retention.
This article defines a practical “eDHR evidence pack”: the 12 records and exports that survive real audit conversations. In the SG Systems Global model, V5 Traceability links execution truth from MES workflows, governance truth from QMS controls, and movement truth into a single operational history. The goal is not to store documents. The goal is to enforce control at execution time so the record is defensible by design.
Out with paper travelers, in with eDHR: evidence that is captured at execution time is the only kind that survives without reconstruction.
1) The Inspection Standard: “Control Proven” Beats “Record Completed”
Paper travelers feel safe because they are familiar, but they are structurally weak in the one moment that matters: when the investigator asks you to prove what happened, when it happened, and who had authority. This is why modern inspection posture treats the DHR as an execution-and-evidence standard. The record must be contemporaneous, linked to identity, and supported by a trustworthy audit trail. If the business must “tell the story” to make the record coherent, the system is already in reconstruction mode.
V5’s eDHR posture starts with a blunt premise: the system should make incorrect actions hard and correct evidence capture normal. If execution is governed (identity, authority, sequencing, and evidence), then inspection readiness becomes a property of the operating system, not a hero effort by Quality.
2) What “Paper Travelers” Get Wrong: Four Predictable Failure Modes
Paper travelers fail in predictable ways. First, identity drifts: components are swapped, labels are reprinted, or units are reworked without reliable linkage. Second, timing becomes contestable: entries are filled in later because the system does not require execution-time capture. Third, authority is ambiguous: sign-offs are not tied to a controlled role model or user access management. Fourth, exceptions are buried: deviations and rework are handled as side conversations instead of governed events.
An eDHR fixes these not by “digitizing paper,” but by enforcing control logic: identity captured at execution, signatures bound to authority, exceptions governed in workflow, and evidence packs generated as system outputs.
3) The eDHR Evidence Pack: The 12 Records That Survive Audit Conversations
A practical eDHR evidence pack is not a single PDF. It is a set of linked records that let an investigator verify identity, execution, acceptance, and decisions without gaps. Below are 12 records and exports that consistently matter in real inspections.
- Device / lot genealogy. A defensible linkage from finished device or lot to consumed components and subassemblies, consistent with end-to-end lot genealogy.
- Work order execution history. The step-by-step execution record showing what was performed, in what sequence, and by whom, aligned to controlled instructions and work order execution.
- Material identity confirmation. Proof that the right material was used at the moment of consumption, tied to material identity confirmation (barcode/ID verification, not narrative).
- Incoming acceptance evidence. Receiving / inspection disposition records tied to supplier lots and acceptance decisions, aligned to incoming inspection.
- In-process acceptance and quality gates. Step-level acceptance checks that were required, executed, and passed/failed, aligned to in-process quality gates.
- Test results and review evidence. The raw results plus the review/approval record that shows conclusions and authority, aligned to laboratory analyses review.
- Labeling / identification verification. Proof that the correct label/version/identifier was applied and verified, aligned to label verification.
- Quarantine, hold, and release history. A complete status timeline showing when material or product entered quarantine, why, and what released it under QA disposition.
- Nonconformance and deviation record. The event record that proves detection time, containment, investigation linkage, and resolution, aligned to deviation / nonconformance.
- CAPA linkage and closure evidence. Proof that systemic issues were addressed and verified, including CAPA and a CAPA effectiveness check.
- Training / authorization proof. Evidence that the operator was authorized for the task at the time of execution, tied to a training matrix and role logic.
- Audit trail + electronic signatures export. A combined view showing who performed key actions, when they occurred, what changed, and which steps were signed, aligned to audit trail and electronic signatures.
These 12 items are not “nice to have.” They are how scope stays narrow. When the evidence pack is coherent, the firm can answer “what happened?” without expanding the question to “what might have happened?”
4) Enforced Holds: Why “Stop Movement” Must Be a System Property
Inspection risk spikes when suspect product can still move. A hold that lives in an email thread is not a hold. eDHR defensibility requires enforced status logic: if product is suspect, it enters quarantine, and downstream actions become impossible until disposition is made under defined authority. That is how a firm proves containment without storytelling.
V5 strengthens this posture because execution, movement, and quality status share the same identity model. The system does not merely record decisions; it enforces them.
5) Identity Discipline: The eDHR Is Only as Good as Its Genealogy
If identity can drift, the DHR becomes contestable. The operational requirement is identity locked to execution: material verification at consumption, lot linkage through transformations, and reliable traceability from device back to inputs. This is where a true execution platform matters: it captures what actually happened at the time it happened, and ties it into end-to-end lot genealogy that can be retrieved without manual reconciliation.
“We can trace it” is a weak claim. “We can prove it with a system output” is a defensible claim.
6) Exceptions Governed: Where eDHR Wins or Loses Under Pressure
In inspections, the failure mode is rarely “you never had a process.” It is “your exceptions show you didn’t control the process.” If identity breaks, if acceptance fails, if rework occurs, the event must become a governed record with evidence, authority, and closure. That is why deviation handling and CAPA linkage are part of the DHR story, not separate paperwork.
V5 treats exceptions as first-class operational records: triage, evidence capture, assignments, and closure are governed in-system. When questioned, the business can show control without rewriting the story.
7) Platform Map: How V5 Produces an Audit-Ready eDHR
The eDHR posture is delivered through the platform and modules: V5 Solution Overview, Manufacturing Execution System (MES), Quality Management System (QMS), Warehouse Management System (WMS), and V5 Connect (API).
Operationally, MES captures “what actually happened,” QMS governs “what is allowed and what must happen next,” and the unified identity model preserves genealogy and evidence continuity. When those layers share the same truth, the DHR becomes an output of normal operations: fewer gaps, fewer “late entries,” faster retrieval, and stronger defensibility when the conversation turns serious.
Paper travelers look complete until an auditor asks for timing, authority, and scope. eDHR wins when those answers are system outputs.
8) Bottom Line: Retiring Paper Travelers Is a Risk-Reduction Decision
Out with paper travelers, in with eDHR is not a modernization slogan. It is a risk-control decision. An audit-ready eDHR evidence pack proves execution without reconstruction: identity continuity, acceptance evidence, governed exceptions, controlled release, and audit-grade signatures and trails. When the evidence chain is produced at execution time, inspection readiness becomes normal—and 483-level conversations become shorter because scope stays provable.
