Production · Electronic Batch Record
Every lot, with its complete history.
The approved formula becomes the order, the order becomes the step-by-step, and every step becomes a signature. The batch record builds itself while you manufacture.
What changes
Goodbye to the paper form
filled in at the end of the shift.
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One current formula
The master manufacturing instruction brings together materials, packaging, equipment, line and steps. Every order uses the current version and keeps a record of the one it was made with.
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Signatures in the moment
The operator and the verifier sign every critical step with the real date and time. Pauses and reopenings are recorded.
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Release with everything in view
Batch record, test results, approved materials and the lot’s nonconformities in one place, so you decide based on evidence.
How it works inside
A production order, step by step.
When you create the order, the lot number is built automatically from your structure. As it runs, every step is signed and added to the batch record.
Lot number
Unique, readable and generated by the system: it never repeats.
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Line clearancePerformed by Ana R. 07:02 · Verified by Luis M. 07:05
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Weighing · Glycerin USP · lot GL-2398 · 25.000 kgPerformed by Ana R. 07:20 · Verified by Luis M. 07:22
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Heat oil phase to 75 °CPerformed by Jorge P. 08:10 · 75.4 °C
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Emulsify 10 min at 3,000 rpmPerformed by Jorge P. 08:41 · Verified by Luis M. 08:52
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In-process control · viscosityRecorded by Quality 09:30 · 12,400 cP · compliant
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Filling · 1,000 theoretical / 986 actualRecorded by Jorge P. 10:15 · yield 98.6%
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Order completed · batch record readyPending quality release
Release
From the lab to shipping, without losing the thread.
Production requests the testing, the lab records the results and the person with authority releases the lot. Its status changes in the warehouse at that very moment.
01
Test request
Straight from the order, with the product’s tests.
02
Test sheet
Results against the item’s quality attributes.
03
Lot review
Batch record, materials, yield and deviations.
04
Lot approved
Available in Logistics for FEFO shipping.
All included
Your plant, from floor plan to released lot.
Design
- Master manufacturing instructions
- Raw materials and packaging
- Steps with controls
- Print templates
Plant
- Facilities with an interactive floor plan
- Production lines
- Equipment with history logs
- Area and equipment cleaning
Execution
- Orders and calendar
- Line clearance
- Performed-by and verified-by signatures
- Pause, complete and reopen
Control
- Multi-level requirements
- Material requisitions
- Test requests and test sheets
- Nonconformities from the order
From the blog
Production guides for your plant
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15 min
Instrucción de manufactura: de la fórmula a un paso a paso que no deja dudas
Cómo escribir una instrucción de manufactura clara: materiales, equipos, pasos con parámetros, controles, doble verificación y rendimiento. Con ejemplo resuelto.
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14 min
Numeración de lotes: una estructura que te diga algo de un vistazo
Numeración de lotes: cómo diseñar un número único, legible, con producto y fecha, validar la capacidad del consecutivo y manejar sublotes, reprocesos y predefinidos.
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14 min
Fórmula maestra versionada: por qué tu Excel de fórmulas es un riesgo
Por qué una fórmula en Excel es un riesgo y cómo controlar la fórmula maestra: versiones, estados, vigencia, control de cambios y orden amarrada a su versión.
Bring one of your formulas into the electronic batch record.
In your free trial you can turn on Production for 15 days. If you prefer, we will walk through one of your formulas with you in a 45-minute demo.