Industries · Pharmaceuticals

From Weighing to Release, One Operation

Connect batch records, deviations, and in-process control to your ERP and to the audit. Move the floor from paper and Excel to a single audit-ready record.

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The critical chain
1
batch record

Every step from weighing to release is written to the same record. One broken link in the chain means a day in quarantine.

Weighing
Barcoded, at the source
Granulation
Process parameters
Tablet / Capsule
IPC: weight, hardness
Coating
Humidity, temperature
Packaging
Serial number, traceability
Release
QC and e-signature

Every step is written to the same batch record. Kuika moves the record from paper to screen, into a single audit-ready file.

A broken link is a quarantine day

One gap in the record chain delays the release of the batch.

A heavy documentation burden

Paper batch records and manual signature rounds repeat with every batch.

Being audit-ready

Global manufacturers now manage this in real time, not by searching for files.

What do GMP manufacturers build with Kuika?

GMP manufacturers use Kuika to close the gap between the floor, the ERP, and the audit. Electronic batch records, tier meetings, in-process control, deviation and CAPA management become apps that run on the line and write back to the ERP. Your existing ERP, LIMS, and PLC/SCADA investment stays in place. Kuika is the operations and workflow layer that connects the floor to the ERP and to the audit.

Three constraints in pharmaceutical manufacturing

The batch record is still on paper.

Manual signature rounds and fragmented documents recreate audit risk with every batch.

Deviations are analyzed after the fact.

QC results in Excel and the shift logbook do not raise real-time alerts.

Line planning runs on experience.

The impact of downtime and deviations on the plan shows up only after the delay has grown.

An operations layer on top of your ERP and line sensors

AI-assisted development.

Apps that fit the batch and audit cycle, live within weeks.

When the SOP changes, the app changes.

Regulatory and SOP updates do not wait for a long development cycle.

Integration out of the box.

SAP, the lab, the floor, and the e-signature infrastructure in one operational flow.

USE CASES

Which apps do pharmaceutical manufacturing teams build?

Electronic batch record (eBMR)

Every step from barcoded weighing to release is written to a single record, followed by automatic data collection from line equipment.

Result: A single audit-ready file instead of fragmented documents.
Tier meetings and action tracking

Quality, EHS, and downtime data on one board; action owner, due date, and status in the system. An overdue action escalates to the next tier.

Result: No action is lost in the shift logbook.
In-process control (IPC)

Recording and limit checks for control points such as weight, hardness, and moisture go digital; a deviation is flagged at the source.

Result: A defective product does not move to the next stage.
Deviation, CAPA, and audit readiness

Deviation, change control, CAPA, and audit processes move from paper to one digital QMS; the root cause surfaces early.

Result: The risk of audit findings and rejected batches drops.
Lab sampling and quality control

The sample request, analysis, and approve-reject flow produces an automatic certificate of analysis (CoA).

Result: CoA wait time gets shorter.
Production planning and OEE

The plan in Excel connects to the floor in real time; the impact of downtime and deviations on the plan is visible instantly.

Result: A delay is caught before it grows.

Which part of Kuika will you build it with?

Enterprise Vibe Coding

Describe it in plain language, build it in minutes, and own the code.

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Workflow

Model deviation, change control, and release approvals in BPMN 2.0; e-signature is part of the flow.

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KuikAgents

Ask which root causes recurred this month, and get the answer from your deviation records and your ERP.

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KuikApps

Start from ready-made apps and tailor them to your own SOPs.

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SUCCESS STORIES

We are not entering the industry from scratch.

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Nobel İlaç · MES

From work order to shipment: barcoded weighing, EBR, IPC limit alerts, maintenance records, and an OEE dashboard.

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Nobel İlaç · Tier 4

A daily meeting and action tracking system where quality, EHS, and downtime data come together on one board.

Integration

Not an alternative to your ERP. The layer that connects the floor to the ERP and to the audit.

SAP
Logo
Netsis
Oracle
LIMS
PLC / SCADA
Line sensors (IPC)
E-signature infrastructure
Environmental monitoring systems
REST, SOAP, MCP

You are not building alone.

Consulting

We start with a baseline measurement and decide together which process comes first.

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Optima

AI-assisted optimization for catching scheduling, vehicle routing, and slaughter sequencing.

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Support and Maintenance

Keep your apps standing through peak season and every 45-day cycle.

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A four-week start.

1
Site visit and scope

Department-based prioritization: business value, urgency, and effort are scored together.

2
Tier flow and first demo

The Tier 4 model is extended to the other tiers; screens are reviewed with the floor team.

3
Pilot on one line

Digital traceability replaces paper forms; results are tracked against the baseline.

4
Rollout

Production planning and IPC, then QMS and energy monitoring go live based on measured results.

Frequently Asked Questions

Everything you wanted to know.

Have a question about your own facility?

Contact Sales
NEXT STEP

Let’s digitize the operation from weighing to release, together.

We start with a site visit, then continue with the Tier flow and a pilot on one line.