EBR software in the pharmaceutical industry

EBR Software is an MES solution specially designed for the pharmaceutical sector. At MESbook we are experts in implementing this management and control system to extract all its advantages and benefit the different companies. 

Index

What is EBR software?

To understand what EBR software is, it is necessary to pay attention to its acronym and definition. EBR stands for Electronic Batch Record, which in English means electronic batch record.

Therefore, only with its definition it is possible to understand what is the main feature, advantage or utility of this system: it puts an end to the paper in the factories and digitizes the information, also ensuring robust compliance with the standard. In addition, when we refer to EBR software, it always refers to the pharmaceutical sector.

EBR is a Mes solution for factories, i.e. a production control system solution for the pharmaceutical and cosmetics industry that complies with ISA 95.

ISA 95 is an international standard of the International Society of Automation to create a standard between the company and the different control systems.

An EBR software is, in short, a system for digitizing and replacing paper records of manufacturing batch actions. Many utilities are derived from it, e.g. it can digitally design product specifications, ensures data integrity and supports workflows.

On the other hand, there are different EBR software or rather, there are different levels within the software for electronic batch recording. These are the two main levels:

  • Instructions in digital format: in this case the instructions are in a digital platform.
  • Automated instructions in digital format and interfacing with control systems: at this level, data capture of production processes can be automated, eliminating errors and saving time.
 

Main advantages of EBR solutions in the pharmaceutical industry

These are the main advantages of EBR software:

- Manufacturing guide in digital format

Design of a very clear and simple manufacturing guide that homogenizes and eliminates errors and variations.

As there is only one, all specifications are in the same place and it is easier to keep them up to date and execute them without error. In other words, all operations and steps are governed by the same source.

- Digital control of manufacturing interconnected with systems, machines and operators: Corrective actions.

In addition, the system itself makes it very easy to execute all the processes necessary to comply with the standard and ensure quality and safety, and guarantees that they are being followed and carried out by all the agents involved , such as operators and machinery, at the right time. The orders are executed in a more controlled way, at a higher speed and always taking care of non-conformities as they arise.

- Intelligent exception analysis

Another great advantage of EBR solutions is that it has an exception report. In other words, you can select that only batches that do not comply with a series of conditions or with certain characteristics are analyzed. Thus, only batches that have had performance problems, that do not meet the requirements or have been delayed, are checked for control.

- Intelligent control system, full responsibility, eliminates errors

This is one of the advantages that most control and management software aims to achieve. But when we talk about EBR software, we are talking more about a solution that allows to reduce the variables, that is, the errors of all the processes involved, minimizing improvisation.

- Tracking, traceability and visibility

Another advantage is that, thanks to its unique guidance, digitized parameters, clear guidelines and some of its more specific advantages such as exception analysis, the EBR software is easily traceable. That is, it is easy to follow a path to know all the actions and processes that have been carried out and by whom (digital signature), also with Full audit trail for traceability beyond the DB. In this way, the authorities in charge of tracing them can see their task facilitated.

On the other hand, it can provide all the information related to all processes in a very clear and graphical way that not only benefits the authorities or personnel with managerial and decision-making capacity, but also the operators themselves.

- Cost reduction and time savings

Saving time saves costs and vice versa. The automation or systematization capacity of EBS software is one of its main points, and the digital registration process reduces errors, costs and time. We invite you to read more about theOEE definition .

- Sustainability, one of the benefits of the EBR system for pharmacies

The main advantage or the main feature of EBR software is the elimination of paper and consequently another associated advantage is the help to the environment. This enhances the sustainability of a company and also improves its brand image and corporate social responsibility.

There should no longer be a series of tangible pollutants, but everything is digitized, making access and transmission easier, and also reducing costs and environmental damage.

- Physical space is freed up

Another consequence of the elimination of paper is that it increases the available space. Information can be stored in millimeter-sized locations and no longer occupies large rooms or closets. The company's headquarters will gain space and may even be able to reduce storage costs.

- A stepping stone to overcome the challenges of the pharmaceutical industry

EBS software is a great help in overcoming some of the main challenges in the pharmaceutical industry:

One of them is the creation of a quality system in the pharmaceutical industry thatis regulated, robust, easy to update and follow, and that ensures that it is properly executed to guarantee the standard and supply safe and high quality medicines, without being dependent on people.

 Also, reduction of investigation times. Batch-to-batch comparison and early detection are good tools.

Other aids to the pharmaceutical industry are the elimination of time-consuming actions that are repeated due to an error or irregularity or the creation of a regulated environment that facilitates the control and management of each step.

- Other advantages of EBR software

  • The EBR solution adapts to all manufacturing processes and different brands. It is versatile.
  • It does not need direct supervision to operate.

Experienced in the MES system for pharmaceuticals

At MESbook we have been working for years with EBR solutions for the pharmaceutical sector with great results. We have been able to test and consolidate all the advantages that this software represents in the different companies and factories to verify its full potential and the possibilities of use. In addition, we are up to date with the trends in the pharmaceutical industry and we adapt to them.

Although in principle it is known as the system for the elimination of paper in pharmaceutical companies, its advantages go beyond that, although they start from the same common base: to speed up, control and improve production and quality techniques. Contact us for more information.

Concepcion Albert

Assistant to Commercial Management

Concepcion Albert

Industrial Engineer with more than 15 years of experience in leadership and operations management, developed in the UK and Spain in the food industry and others. Used to train, lead and motivate teams oriented to the achievement and attainment of objectives within a culture of Continuous Improvement, as well as the creation of new business areas.

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