Electronic Batch Records (EBR)
Accelerate and automate EBR reporting. Get a seamless flow of validated documentation across the plant. Produce safely and in accordance with ALCOA+ and GMP frameworks.
EBR - produce safely and in accordance with standards!
Electronic Batch Records is a state-of-the-art solution for creating workflows with specific conditions, creating personalised forms for each product, automatically downloading data, and generating detailed reports on the production of a selected batch. Digital documentation provides irrefutable proof of the correct execution of each stage of the process. Choose EBR from ANT – a proven provider of state-of-the-art technological solutions – and produce medicines and cosmetics safely and in compliance with current standards!
What is EBR?
Learn how EBR works in 4 easy steps!
1.
Use workflow planning tool to model MBR documentation flow
- Build a dedicated workflow for a product or product group
- Assign a list of tasks to be performed at any stage of the process
2.
Create documentation MBR templates with Builder
- Display all processes and templates
- Edit the project using a tool that allows you to add sections and drag and drop fields (text, selection, date, label and others)
3.
Use production execution module to:
- Handle the start-up of a production order
- Validate of the process before the start of production
- Guide the operator through the various stages of production with display of analytics
- Automatically register an order fulfilment
- Automatic data capture
- Automatic form filling based on downloaded data
4.
Generate reports in PDF
- Automatically generate a PDF report by the EBR with a summary of the batch release
- Store all generated reports in the system
EBR Reporting
EBR collects information on the production order and confirmation of activities performed or not performed. It enables the electronic signing of documents, monitoring of production progress, as well as automatically ordering a sample for testing and comparing the sample with set quality tolerances to determine compliance and batch release.
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
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.
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.
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.
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.
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.
Enter the Future of Manufacturing with EBR Powered by LIMS
In the dynamic world of manufacturing, electronic batch records (EBR) have emerged as a game-changer, revolutionizing the way companies produce goods. And when seamlessly integrated with a Laboratory Information Management System (LIMS), the potential for transformative change knows no bounds. For manufacturing professionals seeking to elevate their operations, here’s why exploring EBR in conjunction with LIMS is an opportunity you can’t afford to miss:
- Digitalizing Batch Documentation
- Ensuring Regulatory Compliance and Audit Readiness
- Streamlining Workflows and Process Efficiency
- Enhancing Product Quality and Traceability
- Leveraging Analytics for Continuous Improvement
ALCOA+
ALCOA+ is used to verify that the highest quality and safety standards are met – conditions essential for the correct production of pharmaceuticals. The EBR collects the original data records, thus ensuring that the data taken from the machines during processes is reliable. The ANT system is compatible with the ALCOA+ framework. Every rule is presentable in the system in the event of an 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
Electronic Batch Records - an essential tool for the industrial production of pharmaceuticals and cosmetics
The pharmaceutical and cosmetics markets are some of the most demanding production environments. In order for finished articles to go on sale, it is necessary to produce according to certain specific standards. One of these is GMP (Good Manufacturing Practice), a set of standards used during production in the pharmaceutical and cosmetics industries. Compliance with Good Manufacturing Practice is required by pharmaceutical law.
EBR as a way to meet the 10 GMP principles
With MBR templates, procedures, instructions or recipes are well known.
The EBR enforces the implementation of production processes according to procedures and prevents the use of unauthorised actions.
EBR uses traceability to check the materials used in production
The system collects information about the ready changeover and gives the green light to start production on the machine in question.
Enforcing adherence to procedures reduces the risk of contamination.
The EBR digitally guides the operator and every important operation must be approved by an authorised person
The EBR checks the next steps and reports them as OK/NOK, this information is available on an ongoing basis to those responsible for control
Standardisation of the workstation is essential to comply with procedures related to sterile production.
All process data are collected and recorded on digital forms, giving access to a full view of the production details of each batch.
With EBR, you know exactly who carried out and controlled a particular production step.
Eletronic Batch Records - Explore the possibilities of Paperless and keep digital records
Electronic Batch Records is one component of the Paperless tool responsible for creating digital documentation. Paperless makes it possible to plan workflows in all processes and create production documentation tailored to this plan.
Master Batch Record allows the creation of personalised forms covering the steps that must be carried out for production to run according to plan, as well as defining OK/NOK paths for each step. The operator panel allows handling the start-up of the production order and validation of the process before production begins. The tool guides the operator through the steps of the task.
The EBR records the execution of specific steps and automatically retrieves data to complete the relevant fields in the process form, and then generates a PDF report. In this way, all production documentation is available in digital form. The automatic collection of actual machine data eliminates the possibility of manipulating the information on the form, guaranteeing the reliability of the documentation.
Top 5 benefits of EBR in the pharmaceutical and cosmetics industry
Documents created and stored in digital form are always available for inspection from any device.
The risk of human error in the form of missed signatures and the risk of manipulation associated with the circulation of documents is eliminated. The system reminds the authorised person of the digital signature.
The downloading of data from digital auto-completion machines allows work and information flow to be streamlined and batch release times to be reduced.
Ongoing control of successive stages and strict adherence to procedures eliminates the costs associated with production errors, the need to re-produce batches, and the financial consequences resulting from the detection of irregularities during inspections by authorised bodies.
The use of tools enforcing adherence to procedures allows building the image of a reliable, trusted manufacturer, which adheres to standards and meets the highest requirements related to the production of drugs or cosmetics.
Produce medicines safely and according to standards with EBR from ANT!
At ANT, we specialise in the comprehensive provision of dedicated technology solutions for the manufacturing industry. Automated EBR reporting allows us to create the documentation necessary to demonstrate the correctness of processes at every stage. Using this software, our customers produce tens of trillions of pharmaceutical and cosmetic products each year safely and in a compliant manner.
Choose EBR from ANT and create irrefutable documentation proving that the highest quality and safety standards of production are maintained. Contact us for more information on the software’s capabilities and details of implementing EBR in your facility!
System Presentation
Contact with our Expert
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- A 60-minute online meeting with a dedicated specialist presenting a top system from an industry similar to yours
- Live modeling of your production process
- A budget quotation after the meeting
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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.
