Batch Management - Electronic Batch Record EBR

Batch Management

Control in production begins at the start of the batch. The Batch Management module manages the entire lifecycle of a batch from its creation to its commencement, step by step. This ensures that production processes are traceable, planned, and auditable, leading to fewer errors, faster completion, and more secure auditing.

With this module, each batch is initiated with the correct product, recipe version, resources, and record structure. The production team’s progress becomes clearer, tracking becomes easier; for quality assurance, the question of ‘which batch, under what conditions, with what records was executed?’ becomes transparent from the start. Result: less confusion, faster completion, and more secure auditing.

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Batch Management

Batch Management manages batch creation, product-to-recipe-version matching, resource and station assignment, step-by-step progress tracking, pausing and resuming, closing checks and batch status management. By linking every action to the user, time and relevant records, it creates an end-to-end…

Batch Creation

Batch Preparation

Batch Initiation

Progress and Status Tracking

Batch Closure

Archiving and Traceability

Batch Creation

You initialize the batch in a controlled manner: the product, target quantity, batch number, and basic production information are defined. This ensures that the execution starts with a validated ‘start set’.

Features

Batch Opening and Basic Information
Batch number and identity structure
Definition of the product and production target
Batch types and scenarios

Batch Opening and Basic Information
The fundamental areas such as the product, batch number, planned quantity, etc., are assembled in a standard way; a solid starting point is created for production.

Batch number and identity structure
The unique identifier of the batch is finalized; a traceability system is established to eliminate confusion.

Definition of the product and production target
It is determined which product and target output will be produced for which output; the scope of the execution is clear from the start.

Batch types and scenarios
Different scenarios such as normal production, repeat production, or reprocessing are controlled in a structured manner; the process is flexible but disciplined.

Batch Preparation

The correct recipe version and appropriate resources are selected before the batch is initiated; necessary prerequisites are checked. The aim is to remove the risk of ‘starting production with the wrong recipe’ as early as possible.

Features

Recipe Version Selection
Template and form set binding
Resource and station assignment
Prerequisite control list

Recipe Version Selection
The batch is linked to the correct recipe version; the production execution proceeds on validated and compliant standards.

Template and form set binding
The relevant templates for batch records are linked; data collection on-site becomes consistent.

Resource and station assignment
The production to be performed on which step, station, or equipment is defined; roles and responsibilities are clearly defined from the start.

Prerequisite control list
Critical controls are checked before production; incorrect or incomplete setup is prevented from entering production.

Batch Initiation

The batch is initiated in a controlled manner into the execution process. This step ensures that the batch enters the ‘active production’ status and the step-by-step execution begins on-site.

Features

Batch Initiation and Status Transfer
Creation of start records
Authorization and role control
Start time trigger and audit trail

Batch Initiation and Status Transfer
The batch enters the active status; the execution screens and on-site steps are made available for use.

Creation of start records
Basic records for the batch initialization are automatically created; traceability is established from the start.

Authorization and role control
Initiation permission is constrained based on role-based access control; initiation can only be performed by authorized users.

Start time trigger and audit trail
The ignition is recorded when the batch is initiated; a strong audit trail is created for monitoring purposes.

Progress and Status Tracking

Progress tracking, pending tasks, completed validations, and open risks are visible. The answer to the question 'Where is the batch now?' becomes clearer for management; the question 'What is the next task?' remains for the site.

Features

Progress tracking by step
Batch status and mileage
Hold and Continue
Hold and Continue List

Progress tracking by step
Progress by step

Batch status and mileage
Batch status is categorized and visible; critical stages and mileage are highlighted.

Hold and Continue
The batch can be suspended and restarted in a controlled manner when necessary to maintain process integrity.

Hold and Continue List
Open validations and tasks are listed to reduce the risk of forgetting and delays.

Batch Closure

The batch is closed under 'batch closure conditions' upon completion of production. Defects such as missing signatures and open deviations do not close the batch; this allows for more regular audits and batch release.

Features

Batch Closure Checklist
Inspection of missing records and signatures
Inspection of open exceptions and deviations
Batch Closure and Closure Record

Batch Closure Checklist
Standardization of mandatory batch closure controls to maintain batch discipline.

Inspection of missing records and signatures
Identification of missing fields and signatures for automated correction to reduce the need for manual intervention.

Inspection of open exceptions and deviations
Prevent batch closure when exceptions or deviations are open to control quality risks.

Batch Closure and Closure Record
Record the batch closure and closure date to produce strong traceability in audits.

Archiving and Traceability

After closure, records are archived in the 'historical production database'. This step provides quick access, traceability, and reportability for audits and internal evaluations, making the process more streamlined.

Features

Batch Archiving and Search
Batch-recipe traceability
Batch history and process records
Data ready for report packages

Batch Archiving and Search
Quickly locate batches based on criteria such as product, date, and batch number.

Batch-recipe traceability
Identify which recipe version was used in which batch to create strong traceability.

Batch history and process records
Record all batch activities in chronological order to ensure transparency and control.

Data ready for report packages
Maintain the batch data in a consistent, organized, and ready-to-use format for reporting and analysis.