What is an Electronic Batch Record (EBR)?
An Electronic Batch Record (EBR) is a digital record that contains all the information related to the manufacture of a specific batch of a product. It is a paperless version of the traditional batch record used in the manufacturing industry. An EBR system is designed to capture and store all data and records generated during the production process of a batch, including information on raw materials, production steps, quality control testing, equipment used, the different personnel involved and any deviations that are made from the standard operating procedures.
Batch records ensure that all production activities are accurately documented to maintain product quality. EBR systems facilitate this task with features such as automated audit trail or highlighting of out-of-specification results for entered data. Overall EBR systems can allow manufacturers to identify, investigate and correct deviations faster and more effectively. This improves manufacturing efficacy and promotes a proactive approach to assuring product quality thus reducing the risk of recalls.
What information does an Electronic Batch Record contain?
An Electronic Batch Record contains the following information:
- Raw materials: Information on the raw materials that are used in the production process, including lot numbers, quantities, storage conditions and expiration dates.
- Production steps: Detailed description of the manufacturing steps (eg. unit operations and corresponding phases), instructions of the actions to be taken by the manufacturing operators, documentation of start & end times, equipment information (ID numbers, calibration dates and maintenance records), records of the personnel involved and any deviations from standard operating procedures.
- Quality control testing: Results of all quality control tests performed during the production process, including raw material testing, in-process control (IPC) testing and finished product testing.
- Deviations: Documentation of any deviations from the standard operating procedures, including the full descriptive details, reason (apparent root cause) for the deviation and the corrective actions taken.
- Environmental conditions: Information on the monitored environmental conditions during the production process, including but not limited to temperature, humidity, pressure overlay and other relevant conditions.
- Batch reconciliation: Details on the reconciliation of the quantities of raw materials used, in-process materials and finished products, including any discrepancies and the corrective actions taken.
Benefits of using an Electronic Batch Record system
In comparison to paper batches, EBR systems increase data accuracy, traceability and visibility while aggregating critical production data in an easy-to-search electronic format.
Some of the key benefits in more detail include:
- Improved efficiency: EBR systems can be set up to automatically collect data from other electronic data sources in the manufacturing ecosystem such as equipment, automation layers, historians, environmental monitoring & quality control testing databases. This eliminates redundant manual data transcriptions which are labor intensive and error prone.
- Increased accuracy: The automatic extraction of data described above increases data accuracy by mitigating the risks of manual data transcription errors.
- Improved manufacturing consistency & compliance: EBRs can be equipped with an automated audit trail resulting in a near-exhaustive traceability of the manufacturing process. Furthermore, EBR can be set up with targets/specifications that trigger a warning/error message when an unexpected value is recorded. This immediately identifies deviations from the standard process and allows the manufacturer to implement corrective actions to salvage a batch.
Some EBR systems can dictate the sequence in which manufacturing operations are executed thereby further ensuring operator compliance with standard procedures. E.g. Step 2 cannot be completed until critical values from Step 1 are entered and actions are confirmed.
- Improved data integrity, traceability & reliability: The combination of audit trails, automated data extraction (from instruments and other electronic data sources) and out-of-specification warning capabilities drastically improve the integrity, traceability and reliability of critical manufacturing data.
- Cost savings: This in turn drastically reduces costs associated with deviations, batch rework, reprocessing or, in worst-case scenarios, product recalls.
- User experience: EBR systems can provide detailed workflows with stepwise sequential instructions for the manufacturing operator. This can be more intuitive and easier to follow than paper-driven processes, which simultaneously increases efficiency and reduces the risk of operator error.
Choosing the right Electronic Batch Record solution
A well selected and implemented EBR can streamline and improve the efficiency of manufacturing processes while simultaneously increasing quality assurance through automated data integrity and traceability.
Conversely, a poorly selected EBR can increase the IT and administrative overhead of a manufacturing process, as well as the workload of the operators on the shop floor.
Here are some key steps to consider when choosing an EBR solution:
- Define the business requirements: Identify the organization’s specific needs and requirements for an EBR solution. This includes understanding the data that needs to be captured, the corresponding documentation requirements and the regulatory compliance requirements.
- Research available solutions: Research and evaluate EBR solutions that meet current business requirements and can evolve with your needs. Consider factors such as implementation overhead, ease of use, scalability, integration or compatibility with other systems and vendor reputation or experience in your field.
- Evaluate regulatory compliance: Ensure that the EBR solution is compliant with regulatory requirements, including FDA, EMA, and other relevant regulations. Verify that the vendor has experience working with regulatory bodies and can provide the necessary compliance documentation.
- Check customization capabilities: Ensure that the EBR solution can be customized to meet specific business needs, including the ability to create and review batch records, access real-time production data with easy integration with other systems in the business.
It may be worth considering how much flexibility your EBR system will need. A hybrid approach may be suitable. For example, a system that stores data extracted from manufacturing or analytical instrumentation and/or quality control databases, while also allowing operators the ability to manually enter critical information in specific circumstances.
- Test the system: Test the EBR solution with a pilot project to verify that it meets business requirements and that it is easy to use. This includes testing the system’s ability to capture data accurately and create electronic batch records.
- Consider security measures: Ensure that the EBR solution has robust security measures in place to protect sensitive data. This includes encryption, user access controls and data backup procedures.
- Evaluate vendor support: Evaluate the vendor’s technical support, including help desk support, software updates and system maintenance.
Choosing the right electronic batch record can help maximize efficiency, quality assurance and compliance
In summary, selecting the right Electronic Batch Record system can really help to maximize efficiency and compliance and is an important decision that can significantly impact the manufacturing process.
To select the right Electronic Batch Record system, it is important to clearly define the business requirements and conduct thorough research on the different types of Electronic Batch Record solutions available on the market, train staff effectively on how to use the system and understand what different modules an Electronic Batch Record system contains in order to select the right solution to meet your business needs.
Ultimately, choosing the right Electronic Batch Record system can help streamline the manufacturing process, speed up processes, reduce reliance on paper-based systems, improve data accuracy and reduce the risk of human error, resulting in increased productivity and organizational profitability.
IDBS PIMS software can help with your electronic batch record needs as it seamlessly combines product, process and patient data across the BioPharma lifecycle and supply chain, providing insights that accelerate process understanding to ensure product quality. Learn more about PIMS.