Türkçe 
English 
EBR (Electronic Batch Record) is a system that enables the digital management of production recipes, process steps, and critical production parameters. With EBR, the system can define which raw materials, in what quantities, in what process sequence, and under what process conditions a product will be manufactured.
Accurate tracking of recipe and process parameters is critical for production repeatability and consistent quality. Values such as temperature, time, pressure, speed, pH, humidity, weight, or mixing duration can directly affect the production outcome. EBR helps make the process traceable from start to finish by associating these values with the relevant production step and batch.
How to Manage Production Recipes with EBR?
1. The Production Recipe is Defined in the System.
Recipe management begins with creating the product's manufacturing structure on the EBR. The recipe can define the raw materials to be used, their quantities, the sequence of operations, the equipment, the process steps, and the necessary controls.
This structure ensures that each step in the production process is predetermined, specifying when and under what conditions it will be performed. Operators are guided through the approved production flow.
2. Raw Material and Quantity Information is Attached to the Recipe
For each raw material to be used in the production recipe, a product code, quantity, unit of measurement, and, if necessary, a tolerance range can be defined. This allows for control not only over the type but also the quantity of materials used in production.
Barcode or QR code integration allows verification of whether the operator has selected the correct lot from the correct raw material. The actual quantity used can also be linked to the electronic batch record.
3. Prescription revisions are managed in a controlled manner.
Production recipes may be updated over time due to process improvements, product changes, or quality requirements. Each recipe revision can be recorded as a separate version on EBR.
The new revision can be implemented after it has undergone a control and approval process. Previous production batches can be stored along with the old recipe version that was valid at that time. This allows for a retrospective view of which recipe was used in past productions.
4. Production Steps Follow a Specific Sequence
In EBR, a recipe is not just a list of materials. It can also define the order in which production operations should be performed.
Rules such as not starting the next step until the current step is completed, not continuing production until critical control is completed, or requiring electronic approval for specific processes can be implemented. This supports the standardization of the production sequence.
5. Prescription Usage is Monitored on a Batch Basis
Each production batch can be associated with its corresponding recipe and recipe revision. This allows the system to see which batch was produced according to which production formula and process flow.
This structure is particularly important when investigating quality problems or process deviations. The impact of different recipe versions on production results can be compared.
How to monitor process parameters via EBR?
6. Critical Process Parameters are Defined
Critical process parameters that can affect product quality during the production process can be defined on the EBR. Examples of these parameters include temperature, pressure, time, speed, pH, humidity, weight, or mixing time.
Each parameter is associated with its respective production step. This ensures that which value needs to be monitored at which process stage is clearly defined within the system.
7. Lower and Upper Limits are Determined in the System
Target, lower limit, and upper limit values can be defined for process parameters. Results entered by the operator or automatically obtained from the device can be compared with these values.
Values within the limits are recorded as normal operation, while values outside the limits can be flagged by the system. This structure reduces the reliance on user attention alone for critical process controls.
8. Process Data is Recorded Manually or Automatically.
Process values can be entered into the EBR screen by the operator, or they can be transferred directly via production equipment or automation systems.
Automatic data transfer offers a significant advantage, especially in processes involving high-frequency measurements, by reducing the need for manual input. The choice of method depends on the production infrastructure and system integration.
9. Warning and deviation process is initiated for values outside the limits.
When a process parameter falls outside the defined acceptance range, the EBR can alert the operator. In critical situations, the transition to the next production step can be restricted or additional approval may be required.
If necessary, a deviation log can be created and associated with the relevant process value, user, equipment, and production batch. If QMS integration is available, this log can be transferred to the quality management process.
10. Process History is Reported on a Batch Basis.
Once production is complete, recipe information and process parameters can be reviewed within the same electronic batch record. Which values were recorded at which stage, out-of-limit situations, and approvals can be viewed retrospectively.
This data can be used in batch review, process comparison, and quality assessment. By analyzing process variations between different production batches, areas for improvement can be identified.
What is a Production Recipe in EBR?
A production recipe is a digital production framework that defines the raw materials to be used in a product, their quantities, production steps, equipment, and process conditions. On EBR, the recipe can be directly associated with production batches.
What is a Critical Process Parameter?
A critical process parameter is a process value that can significantly affect the production outcome or product quality. Variables such as temperature, time, pressure, speed, or pH can be considered critical depending on the process.
How does EBR track prescription revisions?
Changes made to recipes can be recorded as new revisions. Each revision can include the effective date, reason for change, and approval information. Past productions can be stored along with the recipe version valid at the time of their production.
How to Reduce Prescription Errors with EBR?
Automatically providing the operator with an up-to-date and approved recipe, verifying material barcodes, performing quantity checks, and sequentially aligning production steps helps reduce recipe implementation errors.
Can process parameters be automatically transferred to EBR?
With suitable technical integration, process data from production equipment, sensors, PLCs, or other automation systems can be transferred to the EBR. This reduces manual data entry and allows measurement data to be recorded in real-time.
What to do if an out-of-limit process value occurs?
The system can alert the user, request additional confirmation, or halt the production flow. The incident can be converted into a deviation log and forwarded for quality evaluation. The course of action to be taken is determined according to the company's process and quality rules.
Can process trends be analyzed with EBR?
By comparing process values from past production batches, changes in specific parameters over time can be examined. This data can be used to evaluate process performance and identify potential deviations earlier.
Which systems can EBR integrate with?
EBR can integrate with systems such as ERP, WMS, LIMS, and QMS. Production orders from ERP, raw material and lot information from WMS, laboratory results from LIMS, and deviation or CAPA records from QMS can be linked to the production process.
What are the benefits of using EBR for recipe and process tracking for a business?
EBR-based recipe and process tracking supports standard production, reduces the use of incorrect materials or recipes, makes critical process values visible, enables faster detection of out-of-limit situations, and facilitates retrospective review of production batches.
Conclusion
With EBR, recipe and process parameters, including product formula, raw material quantities, production sequence, critical process values, limits, user actions, and approvals, can be managed digitally. This allows production to be tracked not only through the final product but also through all critical steps in the production process.
Especially in batch-based and controlled production facilities, managing recipe and process parameters via EBR is a crucial digital infrastructure that supports production repeatability and data integrity. Linking production records with systems such as ERP, WMS, LIMS, and QMS can further enhance process visibility.
To learn more about Centra's Electronic Batch Record (EBR) solution, you can review the EBR solution page or contact us via the information request form.
