Electronic Batch Records (EBR)
A Seamless flow of proven documentation across the entire factory compliant with ALCOA+ framework
Convert paper Manufacturing Documentation in the ANT system and make it full digitable
Create workflow in the system with decision points
Edit workflow by yourself, build subproceses and logic conditions
Create forms with the Builder
Prepare forms for each steps with automated filling data
Prepare forms with different controls: checkbox, enter value, get data from machine/scale, signature
Easily switch from MES panel to the EBR process without losing the current step
Report steps OK/NOK and sign as the step
Report weighing proces, provide LOT and display stock of the scanned batch
Check the speed of the mixers
Validate if the read speed is within the limits
Observe manufacturing phase integrated with bulk proces control
Auto calculate with math formula based on the input
Accept the flow
Automatically generate a PDF report to sum up the production
Key system features
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.
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 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 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.
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.
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.
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.
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.
The ANT system is compatible with ALCOA+ framework. Each principle is possible to be presented in the system in case of audit or inspection.
Available information makes it possible to identify who saved the data and when
Records must be readable after they are written, permanent, adjusted accordingly (if necessary)
Data must be saved at the time it was generated
Data source must be accessible, must be preserved intact
Data must accurately reflect the actions/activities performed
All required information is included and legible
Available for review
Corresponds to established quality standards, e.g. pages adequately numbered, appendices described, signed and dated
Data may not be altered in an unauthorized manner or deleted
integrate and automate
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.