Electronic Batch Record (EBR)

Reliability in manufacturing is achieved not only by reporting results, but by designing and executing the process correctly from the outset. The Electronic Batch Record brings approved manufacturing records into the digital environment, guides operators step by step, and automates critical controls to make batches traceable, consistent and audit-ready.

Missing entries, delayed signatures, inconsistent values and the need for subsequent corrections in paper forms increase both quality risk and the review workload. With the Electronic Batch Record, every record progresses with a timestamp, electronic signature and audit trail, while data integrity principles establish a secure and sustainable framework for manufacturing processes.

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Production Record Designer

Recipe and Version Management

Form and Record Templates

Rules and Limits

Workflows and Approval Flows

Batch Management

My Station

Material Verification and Consumption

Equipment Records and Status Management

Integrated Data Collection

Exception and Deviation Management

Corrective and Preventive Actions

Change Management

Exception-Based Review and Batch Release

Electronic Signatures, Authorization and Audit Trails

Reporting and Analytics

Technical Features of the Electronic Batch Record (EBR)

Production Record Designer

The Production Record Designer digitizes your manufacturing process by breaking it down into steps. It establishes a standardized, traceable and auditable production record framework by defining the tasks to be performed, records to be collected, control points and approval flows for each step.

Recipe and Version Management

Recipe and Version Management manages the draft, review, approval and release lifecycle of recipes; safeguards shop-floor execution through version locking; creates a traceable history with the rationale for changes and impact assessments; and links each batch to the version used, providing an audit-ready manufacturing history.

Form and Record Templates

Form and Record Templates manages all data to be collected during manufacturing steps through standardized forms. By defining field types, required fields, validations, automated calculations, supporting evidence and visibility rules, it ensures that the correct record is created automatically on the shop floor and links every record to the…

Rules and Limits

Rules and Limits; defines intervals for accepting production parameters, tolerances, control frequencies, and actions to be taken in case of deviations. Automates control runs during production; manages processes such as warning, justification, second-party verification, stopping steps, or initiating exception or deviation records in a controlled…

Workflows and Approval Flows

Workflows and Approval Flows enables tasks to be created and routed to the appropriate people, approval steps to be executed sequentially or conditionally, and the entire process to be recorded. Supported by identity, role, authorization and timestamp data, this structure makes delays visible, standardizes approval discipline and produces robust…

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 traceable execution record for each batch.

My Station

My Station presents operators with the active work list for their station, opens the relevant batch step, displays instructions, manages record-entry screens and applies controls in real time. It creates a traceable execution record by linking every action to the person, time and batch, bringing shop-floor manufacturing into line with the defined…

Material Verification and Consumption

Material Verification and Consumption links the materials to be used in manufacturing steps with the batch, verifies the correct material, correct batch number or serial number and correct quantity, records consumption, and initiates controlled processes when deviations occur. All records are stored traceably in the context of the user, time…

Equipment Records and Status Management

Equipment Records and Status Management links equipment to batches and steps, manages equipment statuses, and collects pre-use checks and usage records. Equipment selection is verified, warnings or blocks are applied in nonconforming situations, and exception or deviation processes are triggered when necessary. All records are stored in the…

Integrated Data Collection

Integrated Data Collection associates data received from equipment or enterprise systems with manufacturing steps, combines manually entered and automatically collected data in a single record, and makes the data source traceable. Data collection rules, validations, mappings and error scenarios are managed to ensure that records are created…

Exception and Deviation Management

Exception and Deviation Management; captures and records issues such as exceeding limits, missing records, incorrect materials/equipment, off-process interventions that occur during production steps. It classifies exceptions, opens deviation records when required, collects justification-action-effect information, and automatically associates them…

Corrective and Preventive Actions

Corrective and Preventive Actions manages actions triggered by deviation and exception records. It standardizes root cause analysis, action planning, assignment of responsibility and due dates, verification checks, effectiveness assessments and closure steps. The entire process is made traceable through a timestamped activity history and…

Change Management

Change Management; the creation of a change request, the definition of the reason and scope, the assessment of impact and risk, the planning of necessary actions, the execution of approval processes, and the implementation in a controlled manner. Changes are associated with areas such as recipes, forms, rules-limits, process flows, equipment…

Exception-Based Review and Batch Release

Exception-Based Review and Batch Release; post-production quality reviews are managed based on exceptions. The system flags risky areas automatically, categorizes exceptions, links evidence to relevant records, and standardizes the decision-making process. After the review, decisions such as batch release, conditional batch release, additional…

Electronic Signatures, Authorization and Audit Trails

Electronic Signature, Authorization, and Audit Trails; user authentication and role-based access control prevent unauthorized operations. Mandatory electronic signatures are enforced at critical points; workflow approvals are recorded. Changes, updates, decisions, and significant events are stored in a traceable audit trail; they are reportable…

Reporting and Analytics

Reporting and Analytics manages a batch-based report library, creates packaged output sets such as the Batch Quality File, reports audit trail and electronic signature records, makes the relationships among deviations, corrective actions and changes visible, and links integration reports such as environmental conditions and serialization to the…

Adopt a digital operating model that assures manufacturing quality from the outset instead of inspecting it after the fact.

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Digitally Manage Manufacturing with a GMP-Compliant Electronic Batch Record

Centra EBR digitizes batch records from production preparation through execution, review and release. Step-by-step guidance, automated controls, electronic signatures and audit trails strengthen data integrity, accelerate exception-based review and keep every batch traceable and audit-ready.

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