Master Batch Record

Digitally Manage and Version Process Instructions and Documents

In regulated industries, the master batch record (MBR) is considered a central, version-controlled manufacturing guideline that describes all steps, materials, parameters, and quality requirements for production. The MBR serves as a mandatory template from which an electronic batch record is derived for each individual production batch to ensure consistency, quality, and compliance. The MBR is used as a guided, system-supported process execution and navigates operators step by step through the production process.

With the Master Batch Record mApp, you can compile all MES-relevant elements of the MBR and manage them by version. These include:

• Work plans including operations, material components, production resources and tools, etc.
• Versioned inspection plans
• Questionnaires for digital checklists
• Process templates

The mApp includes the following functions:

• Centralized Creation & Versioning – Creation, management, and release of MBR versions, including controlled change management.
• Structured Process Modeling – Definition of all manufacturing steps, materials, parameters, and in-process controls in a structured, system-validated environment.
• Integrated Formula Management – Mapping of materials, quantities, calculations, and logical process-logical dependencies.
• Parameter Management – Defining and managing limit values, target values, process-related parameters, and associated process information.
• Role- and Authorization Control – Control of access to creation, review, and approval in accordance with GxP requirements.
• Regulatory-Compliant Documentation – GMP and Part 11-compliant structure, traceability, and auditability of the MBR.
• MBR Integration – Providing the MBR as a digital, approved process template for electronic execution in the EBR and other MES modules.

Each master batch record can also be documented and monitored using its own status history. This mApp also serves as the basis for creating and managing electronic batch records.

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 device master records (DMR) or similar collections of manufacturing instructions.

Your Benefits

MBRs ensure clear, digital processes, reduce errors, and guarantee that the most recent, verified version is always used. At the same time, they improve compliance and collaboration because all changes, approvals, and responsibilities are transparently documented. This means:

• Standardized and reproducible process execution for consistently high product quality
• Reduction of operating errors and deviations thanks to clear, system-supported process specifications
• GMP-compliant, auditable manufacturing specifications to support regulatory safety.
• End-to-end traceability and data integrity through audit-proof versioning
• Digital basis for EBR, automation, and paperless production

Technical Information

The mApp Master 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).

Master Batch Record in the MIP Ecosystem

The mApp uses existing objects from a wide range of application areas. For this purpose, MPDV provides the following mApps:

• Work Order Management: Manage production orders.
• Inspection Planning: Manage and plan inspection tasks.
• Digital Checklist: Simply digitalize check lists.
• Recipe Management: Manage manufacturing instructions digitally and control processes intelligently
• Recipe Parameter Management: Digitally manage setting parameters and parameter records.

#compliance #processindustry #regulatedproduction #audit #dataintegrity