Electronic Batch Record (EBR): How to streamline the batch record review and batch release process?

Simplify, Improve, Optimize, Control, Master, Standardize ... these terms are becoming increasingly important in the pharmaceutical industry, both for regulatory reasons and to cope with a constantly growing market, as the current health crisis shows.

What is the Electronic Batch Record (EBR)?

Based on documents in Word? format, the electronic batch record, allows secure data entry, it stores and restores all the information constituting the manufacturing documents in electronic form (Preparation, Production, Laboratory, Monitoring) throughout the execution of manufacturing orders. The electronic batch file facilitates the release of batches by highlighting anomalies: out-of-limits values, missing data, correction of entries.

Its database is open for queries and reports.

The DLE allows to answer more efficiently to the regulatory requirements, in particular on the Data Integrity expectations. Indeed, the use of computerized systems in order to generate an electronic batch record contributes to reinforce the control of the data it contains thanks to an automatic data recovery to the detriment of manual data entry which can generate errors and/or misunderstandings by the various stakeholders (production/quality assurance).

The computerized systems also make it possible to set up blocks and "checks" to ensure that no data is missing for the elaboration of the electronic batch record. In this way, it is also possible to sequence and lock the data entry so that the data is always available at the time it was generated and not entered later, thus ensuring the expected contemporaneity.

The use of electronic batch records also allows for greater reactivity in the event of exceptions or input errors, for example. Thanks to simultaneous access to batch record information, it is easier to act and make the necessary corrections by the various stakeholders while guaranteeing data security and therefore product quality.

A computerized system in a GxP environment requires a high level of control during its evolution. Each modification is subject to change management, potential impact assessments and finally qualification (see: IS qualification (GMP Annex 11 (§2), FDA 21 CFR Part 820 (§820.70i), FDA 21 CFR Part 211 (§211.68a/b)).

The EBR " Electronic Batch Record " to digitize and replace paper batch records and move to the Electronic Batch Record (EBR)

We offer a tool to dematerialize production, quality assurance and quality control records. It saves time in reviewing files thanks to filters on tags that may appear as non-conforming during production, and for which there is a need to process a deviation. It's a visual tool that allows you to focus on the elements you need to spend time on."

We support in the following ways:

• Framing and scoping the project
• Setting up the pilot project
• Streamlining of existing batch files
• Deploying the DLE
• Support and integration.

The use of electronic batch records lies in the reproducibility of operations through locked master data. By using standardized recipes for each batch, production operations are systematically repeated in the same order, thus guaranteeing a unique way of doing things regardless of the batch. Another reason for using DLEs in the pharmaceutical industry is to improve and streamline the manufacturing process. This is possible because the DLE can be accessed simultaneously by several production operators, which makes it possible to collect information on different production steps that are carried out in parallel.

Another important point is the reduction of time for activities related to the production activities, namely

• Decrease in batch record review time: thanks to the DLE, the review circuits are simplified, a more fluid management is implemented and allows the different stakeholders to be notified as soon as the DLE is ready for review.
• Decrease batch certification and release time: instead of waiting for the end of manufacturing for a paper batch record before starting the review for batch release, it is possible, thanks to the DLE, to initiate this review before the end of the batch without interfering in the manufacturing of the current batch.
• Reduction of deviation processing times: with the help of computerized systems, information flows become faster and allow notification of the various stakeholders of upcoming actions.

Certainly, all these gains, verified by the laboratories that have opted for the DLE, are an incentive to embark on a project to implement it. Currently, many initiatives are stimulated by more global digitalization programs. In most cases, the DLE is supported by a computer application such as MES (Manufacturing Execution System).

First set of benefits of the Electronic Batch Record (EBR)

The implementation of eBR / DLE brings tangible gains:

• Decreased review or release time because the system monitors from the beginning of production and alerts if a tolerance is exceeded. This gain will be ensured by the review by exception.
• Increased compliance with the data integrity requirement, which is ensured by the control of the qualified system at its implementation. There is a guarantee of the reliability and traceability of the recorded data.
• The process operations are framed by instructions but also by the computerized system which also allows to guide it. This makes it possible to ensure the reliability of operations. Access rights management is carried out when the system is set up, which makes it possible to control the actions linked to the process or to the review according to the training carried out.
• Reduction of anomalies related to raw data. The digitization of the batch record will avoid the loss of raw data or cross-contamination between two batches.

Second set of benefits of the Electronic Batch Record (EBR)

• Deliver to customers faster,
• Secure the quality of products,
• Ensure regulatory traceability,
• On-line quality control,
• Speed of analysis of multi-batch data
• Compatibility with the controlled environment,
• Decrease the risk of contamination,
• Increased confidence with regulatory authorities (ANSM, FDA, ANVISA...)

Third series of benefits of the Electronic Batch Record (EBR)

• Consolidation: Assemble your various attachments and quality control documents.
• Security: Quality review, Unique PDF generation, Audit-trail, Data Integrity.
• Recovery of your documents: Your documents are transformed into Smart Documents.
• Data entry: Compatibility with tablet format. Intuitive navigation.
• System integration and simplification of the validation workflow

In conclusion

There are also intangible gains due to its dematerialization, the batch file will not have a physical flow and can be released without having to be physically on site. This will increase flexibility and avoid blocking points linked to a physical presence. Moreover, this dematerialization will open the door to the future and to new technologies such as "big data" or "business intelligence" to carry out data forecasting on equipment for example. The implementation of an eBR allows to have multiple tangible or intangible gains in the medium and long term but with a strong investment at the beginning of the project.