Electronic Batch Record

Electronic Batch Record for Regulated Production

Based on a master batch record (MBR), all relevant data is comprehensively documented during production to ensure full traceability. This is recorded in an electronic batch record, abbreviated as EBR. 

The EBR digitally maps the actual execution of the master batch record and replaces paper-based batch documentation with an electronic, GMP-compliant system. All production data, be it machine parameters, material consumption, operator entries, or in-process controls, is recorded electronically — either automatically via equipment interfaces or manually with electronic verification. Through controlled user guidance, integrated verification mechanisms, and audit-proof storage, the EBR helps to ensure complete data integrity in accordance with ALCOA+ and enables efficient, low-error, and auditable production.

The mApp Electronic Batch Record digitally maps the data in the MES and ensures the integrity of this information.

Find below mApp functions:

• Digital Batch Management – Executing all process steps on a step-by-step basis in accordance with the approved master batch record, including mandatory steps, blocking logic, and validation rules.
• Automated Data Collection – Integration with machines, sensors, scales, and MES/SCADA systems for the automatic collection of production and quality data.
• Manual Entry with Verification – User input with plausibility checks, threshold checks, and electronic confirmation, including user identification.
• In-Process Controls (IPC) – Structured recording and evaluation of in-process checks, including automatic evaluation against defined threshold values.
• Deviation and Event Recording – Documentation of deviations, OOS incidents, or additional notes directly for specific process steps.
• Audit Trail – A complete, time-stamped, and immutable record of all GMP-relevant actions and system events, with full traceability.
• Electronic Signatures – Signatures that comply with legal and GMP requirements under FDA 21 CFR Part 11 for multi-step checking and approval processes
• Reporting and Analyses – Generation of auditable reports, KPIs, and process analyses for continuous improvement.

Preview versions of an EBR can be generated at any time during ongoing production and made available as a clear, easy-to-read PDF report.

The product can be validated and complies with FDA 21 CFR Part 11, EU GMP (including Annex 11), and ISO 13485. The mApp can also be used to manage electronic device history records (eDHR) or similar collections of documented data.

Your Benefits

The mApps Electronic Batch Records ensures fully digital, guided production processes that reduce errors and guarantee complete data collection in real time. At the same time, EBRs improve compliance and audit readiness because all steps, deviations, and approvals are automatically documented and can be traced at any time. This means:

• Reduced error rates and deviations with digital guidance and automated data collection
• GMP-compliant, auditable batch documentation, including an audit trail and electronic signatures
• Complete data integrity and traceability through audit-proof storage and ALCOA+-compliant data collection
• Paperless, automated production thanks to an end-to-end digital production workflow 

Technical Information

Die mApp Electronic Batch Record is part of the category Regulatory & Compliance Management of HYDRA X for Process.

The mApp uses data of the Virtual Production Reality (ViPR) of MPDV's Manufacturing Integration Platform (MIP).

Electronic Batch Record in the MIP Ecosystem

The mApp documents data from different fields of application. For this purpose, MPDV offers the following mApps:

• Work Order Execution: Record data in the shop floor based on orders.
• In-Production Inspection: Record inspection data in the shop floor.
• Digital Checklist: Simply digitalize check lists.
• Recipe Management:  Manage manufacturing instructions digitally and control processes intelligently.
• Recipe Parameter Management:  Digitallymanage setting parameter and parameter records.

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