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differentiated capabilities

Electronic Controlled History Record (eCHR): the compliant, paperless Device History Record, built into execution

The Eyelit MES eliminates paper-based history records without sacrificing control. The eCHR is not a bolt-on reporting layer — it is created automatically as work progresses on the shop floor, stored in an immutable blockchain-backed record, and fully compliant with 21 CFR Part 11, ISO 13485, EU MDR, AS9100D and equivalent regulations from day one.

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The Problem

Why paper-based history records are a liability, not a safeguard

Paper-based history records can run to hundreds of pages. Manufacturers who rely on them are carrying operational and regulatory risk at every step of the production process.

version control risk

Outdated work instructions pinned to workstations. Operators work to superseded procedures with no system enforcement.

completeness failures

Missing signatures, illegible entries, and lost pages often surface long after the production step has completed, making corrections costly, disruptive, and a source of audit findings in their own right.

storage cost

$5–15 per archive box per month for the lifetime of the device. Hundreds of thousands in storage costs over a product’s life.

audit exposure

Increased risk of paperwork omissions and corrections documented incorrectly. Slow, error-prone retrieval compounds the problem at audit.

How it works

How eCHR works, automatically, in execution

Step 1

Define the eCHR Profile

Configure what data is captured, structure, triggers, and e-signature permissions.

Step 2

Execute on the shop floor

As operators progress work, all configured quality-critical data is captured automatically into the blockchain record, no manual transcription.

Step 3

e-Sign in context

Configurable e-signature profiles enforce who can sign, the meaning of the signature, and whether live or retrospective, built into the workflow.

Step 4

Review & Approve

eCHR review and sign-off managed on shop floor or in-office. Controlled approval process is itself recorded in the blockchain record.

Step 5

Audit-ready report

An audit-friendly report is generated and stored in the blockchain, retrievable instantly, not from an archive box.

capabilities

Capabilities that make eCHR defensible to regulators

immutable blockchain storage

Quality-critical data is stored in blockchain tables — technically immutable, not just policy-immutable. No database administrator can alter or delete records through a back door. Satisfies 21 CFR Part 11 and equivalent requirements without workarounds.

configurable echr profile

Define exactly which data subset constitutes the regulatory record. Capture far more operational data for continuous improvement; designate precisely what is quality-critical. Structure, triggers, and e-signature rules all configurable per product.

configurable e-signature

E-signature profiles specify the number of signatories required, permissions needed to sign, meaning attributed to each signature, and whether signing is live or retrospective.

system validation

A full validation pack is supplied and available to the customer to facilitate implementation validation. A built-in test plan manager supports IQ/OQ/PQ validation in situ. Customers extend with their own environment-specific test cases rather than building from scratch on unfamiliar software.

process validation

The production manufacturing source of truth, workflows, BOMs, recipes, is built and progressed through validation stages (Virtual Test → Pre-Production → Production → Obsolescence) in a single system. No copying between test and production environments. Evidence of every progression step is retained in one place, e-signed and locked at approval.

deep process representation

The Device Master Record (DMR) is not a PDF referenced at audit time. It is embodied in the workflow definition enforced at execution. Routing, BOM, skills, tools, machine choices, specifications, and process parameters are all version-controlled and linked to the production record.

automatic echr creation

The eCHR is created as a by-product of normal shop floor execution, not assembled retrospectively. Required data, changes, and signatures are captured in real time. Completeness issues that surface at end-of-line QC on paper are eliminated structurally.

single system for execution & compliance

One platform controls production execution and captures eCHR data for both compliance and operational performance. No parallel systems, no reconciliation, no data translation between the system of record and the system of execution.

stepwise implementation

Deploy in stages: start with shop floor execution and immediate productivity gains, then build into eCHR.

partial batch & rework support

Extension routings for triage, investigation, and rework mean the complete manufacturing history of every unit, including non-conformances and rework steps, is retained in one place, with no need to duplicate paper documents for split batches.

Compliance coverage

Built for regulated manufacturing across sectors

Regulatory frameworks addressed

eCHR is designed to satisfy the electronic records, e-signature, and production record requirements across the regulated industries Eyelit serves.

21 CFR Part 820 / QMSR

FDA Quality Management System Regulation (QMSR) to ensure manufacturing is conformant with Current Good Manufacturing Practice (cGMP) and the Device Master Record (DMR)/Medical Device File.

21 CFR Part 11

Electronic records and signatures must be trustworthy, auditable, and equivalent to paper. Blockchain storage and configurable e-signature profiles satisfy this directly.

ISO 13485:2016

Global QMS standard for medical devices. Eyelit’s version-controlled Device Master Record (DMR) embodiment and eCHR satisfy batch and device record requirements.

EU MDR 2017/745

EU market authorization requires technical documentation and full traceability. eCHR provides the immutable production record required.

as9100D

Global QMS standard for aerospace, defense and space sectors.

nadcap

Global standard for validating critical manufacturing processes in Aerospace, defense and space sectors.

The four foundations of defensible eCHR

Any system can claim electronic record capability. These are the technical foundations that make Eyelit’s eCHR auditor-proof.

immutable storage

Blockchain tables, not just access-controlled databases. Technically impossible to alter without detection.

process embodiment

Device Master Record (DMR) lives in the execution system. What is approved is what is enforced, not a document referenced at audit.

configurable e-signature

Unique to individual, timestamped, meaning-attributed, tamper-evident. Fully configurable per workflow step.

validated platform

Validation pack including a full Functional Design Specification (FDS) and test evidence supplied to facilitate implementation validation.

Quote Label print can have an enormous impact on a business if not done correctly, especially when dealing with product labels. An incorrectly printed label could require a product range to be recalled at great expense, or cause irreparable damage to a brand. – Eyelit Technologies

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