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Digital Compliance: the batch record, built layer by layer

In a regulated plant, compliance isn’t a document you assemble at the end — it’s the sum of everything that happened on the shop floor. NEO’s Digital Compliance manages each layer of production in real time, and every managed layer feeds the next, until a complete Electronic Batch Record assembles itself. Your team reviews only what falls outside the expected — Review by Exception — and releases product faster.

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Each layer of Digital Compliance rests on the one beneath it. Together they produce a batch record that is right by construction — not reconciled after the fact.

The six layers of Digital Compliance

1. Resource management
Every resource — equipment, rooms, materials and people — is managed by NEO. It tracks each machine’s status (clean or dirty, qualified) and whether the operator is trained to run it, so the resources in use are the right ones and no deviation surfaces later.
2. Workflow management
Every product follows its own workflow. NEO controls the time in each step and before it — holding time, running time, pauses, operators and quantity produced — so production yield is calculated automatically, with the time spent on every machine and resource captured.
3. Task management
Maintenance, cleaning and setup tasks before and after each step are controlled by NEO, with a record of who did each one and how long it took. If a task raises a compliance issue, NEO blocks the equipment so nothing runs on a non-compliant resource.
4. Process management
Inside each step, NEO keeps activities within their thresholds — the right activity, at the right time, with the right equipment and resource — and collects the evidence of each one, attaching it to the batch record as it happens.
5. Performance management
With everything managed automatically, the data becomes insight: KPIs for data-driven decisions, fed by IoT devices, human input or triggered events, plus alerts on performance deviations in resource allocation, time and equipment.
6. Compliance management
All of it feeds the system to generate the Electronic Batch Record automatically. With Review by Exception, Quality reviews only the exceptions — releasing product faster, reducing stock costs and avoiding supply-chain disruption.

The record assembles itself

When every layer is managed, the Electronic Batch Record is generated automatically from real production data — not typed up afterwards. A Review by Exception strategy lets Quality focus only on the deviations, so batches are released faster and right the first time.

One platform, every layer

Digital Compliance isn’t a separate tool — it’s how the NEO modules work together. NEO FLOW runs the workflow and timing, NEO TASK governs maintenance, cleaning and setup, NEO EBR turns captured evidence into the electronic batch record, and NEO OEE and NEO PI turn the data into performance insight.

Built for the standards regulators expect

FDA 21 CFR Part 11
Electronic records and signatures behind every action, with a verifiable audit trail.
EU Annex 11
Risk-based controls and traceability across the whole production lifecycle.
GAMP 5
A risk-based lifecycle approach, from resources to the released batch.
ALCOA+ data integrity
Attributable, legible, contemporaneous, original and accurate records, by design.

Digital Compliance is designed to support these frameworks. Final compliance depends on your configuration, validation and procedures — NEO gives you the controls, the evidence and the audit trail to sustain it.

See Digital Compliance on your line

Book a demo and we’ll show how one product order flows through every layer — from resource checks to a signed, automatic batch record.

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