Electronic Batch Records (EBR)

A Seamless flow of proven documentation across the entire factory compliant with ALCOA+ framework

paperless

Convert paper Manufacturing Documentation in the ANT system and make it full digitable​

MBR Creation

1.

Create workflow in the system with decision points

2.

Edit workflow by yourself, build subproceses and logic conditions

3.

Create forms with the Builder

4.

Prepare forms for each steps with automated filling data

5.

Prepare forms with different controls: checkbox, enter value, get data from machine/scale, signature

EBR Reporting

1.

Easily switch from MES panel to the EBR process without losing the current step

2.

Report steps OK/NOK and sign as the step

3.

Report weighing proces, provide LOT and display stock of the scanned batch

4.

Check the speed of the mixers

5.

Validate if the read speed is within the limits

6.

Observe manufacturing phase integrated with bulk proces control

7.

Auto calculate with math formula based on the input

8.

Accept the flow

9.

Automatically generate a PDF report to sum up the production

Results

0 %
reduce time of batch control
0 %
batch release time reduction​
0 %
reduce errors and deviations

Key system features

Digital Documentation

Digital Documentation let users to display documentation online at operator panel. Categorized PDFs, images and movies are being displayed for ongoing production.


EBR - Electronic batch record

Operators fills documentation step by step on the Operator Panel. It is a documentation for the whole manufacturing process in electronic way. System makes ensure that steps are fully completed with all the required data. The result of EBR creation is the PDF Manufacturing Documentation file.

Traceability

With Traceability tracking and tracing of the finished good, semi-finished good and raw materials is possible. Ongoing production is being matched with S/N, batches of components and containers. The system validates processes and confirms scanned resources. Labelling process is done automatically in any step of production. With Traceability it is possible to find raw material based on scanned finished good and vice versa - after scanning raw material in which finished goods it was used.

MBR – Master batch record

Creating templates of the MBR by setting all activities in the system in the right sequence. Each activity can be configuration with reporting data type like numbers, text, data read from automation, etc. Those values can be validated against quality limits set in the system.

Paperless

Paperless is responsible for digital guidance of operator - starting from displaying activities (list to-do) for production, changeovers with dedicated documentation (image, document, movie) for each step of production. Any paper form can be transferred to the system thanks to Factory Forms.

Quality inspections

Quality Inspections are automatic way for periodic quality tests with immediate confirmation if measurement is within quality limits. Measurements are being read from automation level or are provided manually by operator. Thanks to SPC report and Shewhart control charts the stability of production is being monitored.

ebr-icons-process

Workflow


System guides and monitors the steps of the documentation as a workflow. It helps to find on what phase, the document is now and what actions must be taken to finish the process together with assigned user or its type. Workflow support electronical signature.

ebr-icons-integration

System
integration

System integration is responsible for receiving inbound data from ERP and for sending outbound data to any other external system. It works in real-time. Different integration ways are supported like web services, intermediate databases or flat files.

ebr-icons-master data

Master
Data

Master Data is a part of the system where production modelling is done. It is a place to specify detailed technology like items, routing, factory structure or production orders.

ebr-icons-master data advanced

Master Data
Advanced

Master Data Advanced is extension for standard Master Data. It is to even model processes even deeper including BOMs, activities for paperless step-by-step instructions, labelling, quality limits, setpoints for machines and S/N products.

ALCOA+

The ANT system is compatible with ALCOA+ framework. Each principle is possible to be presented in the system in case of audit or inspection.

Attributable

Available information makes it possible to identify who saved the data and when

Legible

Records must be readable after they are written, permanent, adjusted accordingly (if necessary)

Contemporaneous

Data must be saved at the time it was generated

Origial

Data source must be accessible, must be preserved intact

Accurate

Data must accurately reflect the actions/activities performed

Complete

All required information is included and legible

Available

Available for review

Consistent

Corresponds to established quality standards, e.g. pages adequately numbered, appendices described, signed and dated

Enduring

Data may not be altered in an unauthorized manner or deleted

Process flow

1.

create
and manage

2.

build
in revisions

3.

integrate and automate

4.

release
to usage

5.

fill
and operate

6.

report

Related articles

Electronic Batch Recording (EBR) is a system for tracking the production process. It includes monitoring the production of various batches, recording production data and generating reports.  

The use of EBR in pharmaceutical production is an important step toward improving quality and safety. Because it ensures that all batches are traceable, with a detailed list of ingredients and their quantities.  

 The pharmaceutical industry has been using EBR for many years, but it has now begun to spread to other industries as well. 

Master batch records are usually used to store the information of a single product. They are usually created when the product is first manufactured. 

Batch records on the other hand, are created when specific products are manufactured. 

The master batch record contains all the information about a given product and can be used as a blueprint for future batches of that same product. 

Batch records on the other hand, capture the details of each individual batch and can be used to track production and quality control data. 

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