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Batch Manufacturing Record Software

Replace paper-based BMRs with a secure electronic solution that standardizes manufacturing, reduces documentation errors, and ensures complete batch traceability from dispensing to release.

Everything You Need for
Electronic Batch Manufacturing

A purpose-built, fully configurable eBMR platform for pharmaceutical manufacturers —
covering every stage from recipe management to batch release.

Electronic Batch Record (eBMR)

Paperless manufacturing records with electronic data capture, digital batch execution, and automatic document generation.

PaperlessDigital
Recipe & Master Batch Record

Configure Master Batch Records (MBR), manage product-wise manufacturing recipes with full version control and controlled revisions.

MBRVersion Control
Manufacturing Workflow

End-to-end workflow from batch initiation through dispensing, mixing, granulation, compression, coating, and batch completion.

End-to-EndConfigurable
Equipment Integration

Automatic equipment verification, calibration status checks, preventive maintenance verification, and equipment log integration.

CalibrationPM Verification
Material Management

Raw material verification with barcode scanning, material dispensing, batch genealogy, and full material reconciliation.

BarcodeGenealogy
Electronic Signatures

Multi-level approvals with digital signatures, reviewer comments, and 21 CFR Part 11 compliant approval workflows.

21 CFR Part 11Multi-level
Real-Time Monitoring

Live manufacturing status, batch progress tracking, process parameter monitoring, and a unified production dashboard.

Live DataDashboard
Audit Trail

Complete activity history with user tracking, date/time stamps, and full regulatory audit support.

ALCOA+Regulatory

Manufacturing Workflow

A documented, GMP-compliant workflow that ensures consistent execution and regulatory compliance across every batch production cycle.

Master Batch Record

Create and maintain approved master manufacturing templates with standardized instructions and process parameters.

Batch Creation

Generate a new batch record by automatically populating data from the approved master batch record.

Material Dispensing

Record and verify raw material dispensing with traceability to approved material lots and quantities.

Equipment Verification

Ensure equipment is qualified, calibrated, clean, and approved before manufacturing begins.

Weighing

Capture and verify material weighing data with electronic checks for accuracy and compliance.

Manufacturing Operations

Document every manufacturing step with real-time process data, operator actions, and timestamps.

In-Process Checks

Record quality checks and process parameters to ensure manufacturing remains within approved limits.

Yield Calculation

Automatically calculate theoretical and actual yields to identify production variances.

Material Reconciliation

Reconcile material usage, wastage, and remaining inventory to ensure complete accountability.

Deviation Handling

Log, investigate, and route deviations through the approved quality workflow whenever exceptions occur.

QA Batch Review

Enable Quality Assurance to review the complete electronic batch record for accuracy, completeness, and compliance.

Electronic Signatures

Apply secure, compliant electronic signatures to authorize manufacturing and quality activities.

Batch Release

Approve and release the batch for distribution after successful completion of all quality requirements.

Reports & Audit Trail

Generate comprehensive reports and maintain a complete, tamper-evident audit trail of every record and action.

Key Workflow Principles
GMP-Compliant
Full Audit Trail
21 CFR Part 11
Complete Traceability
Real-Time Status
Automated Checks

Each step is documented electronically with date/time stamps, user identification, and complete audit trail for regulatory compliance.

Seamless Product Integrations

Zentixs BMR connects with your existing systems — ERP, LIMS, QMS, and more — for a unified manufacturing ecosystem.

Zentixs Labs
Zentixs Labs
Zentixs Track
Zentixs Track
Zentixs Log
Zentixs Log
Zentixs Talent
Zentixs Talent
Zentixs Caliber
Zentixs Caliber
Zentixs BPR
Zentixs BPR
SAP/Oracle ERP
SAP/Oracle ERP
WSM
WSM
 SCADA/ PLS/MES
SCADA/ PLS/MES

Compliance Support

Reliable, secure, and efficient compliance management for regulated industries.

21 CFR Part 11

FDA electronic records & signatures standard for pharmaceutical manufacturing.

EU Annex 11

European GMP guidelines for computerised systems used in pharmaceutical manufacturing.

GAMP 5

ISPE framework for risk-based validation of computerised pharmaceutical systems.

GMP Support

Good Manufacturing Practice standards ensuring consistent quality in pharmaceutical production.

WHO GMP

World Health Organisation's Good Manufacturing Practice guidelines for medicines.

ALCOA+

Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, and more.

PIC/S

Pharmaceutical Inspection Co-operation Scheme — harmonised GMP standards globally.

MHRA

UK Medicines & Healthcare products Regulatory Agency data integrity guidance.

21 CFR Part 11

FDA electronic records & signatures standard for pharmaceutical manufacturing.

EU Annex 11

European GMP guidelines for computerised systems used in pharmaceutical manufacturing.

GAMP 5

ISPE framework for risk-based validation of computerised pharmaceutical systems.

GMP Support

Good Manufacturing Practice standards ensuring consistent quality in pharmaceutical production.

WHO GMP

World Health Organisation's Good Manufacturing Practice guidelines for medicines.

ALCOA+

Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, and more.

PIC/S

Pharmaceutical Inspection Co-operation Scheme — harmonised GMP standards globally.

MHRA

UK Medicines & Healthcare products Regulatory Agency data integrity guidance.

Frequently Asked Questions

A Batch Manufacturing Record documents the complete manufacturing history of a production batch, including materials, equipment, process steps, in-process checks, and approvals.
An eBMR is the digital version of a traditional paper BMR that enables electronic data capture, workflow automation, audit trails, and electronic signatures.
Yes. Zentixs BMR is designed to support 21 CFR Part 11, EU Annex 11, GMP, GAMP 5, and ALCOA+ data integrity requirements.
Yes. Zentixs BMR integrates with ERP, LIMS, QMS, MES, WMS, Electronic Logbooks, and other manufacturing systems.