Replace paper-based BMRs with a secure electronic solution that standardizes manufacturing, reduces documentation errors, and ensures complete batch traceability from dispensing to release.
A purpose-built, fully configurable eBMR platform for pharmaceutical manufacturers —
covering every stage from recipe management to batch release.
Paperless manufacturing records with electronic data capture, digital batch execution, and automatic document generation.
Configure Master Batch Records (MBR), manage product-wise manufacturing recipes with full version control and controlled revisions.
End-to-end workflow from batch initiation through dispensing, mixing, granulation, compression, coating, and batch completion.
Automatic equipment verification, calibration status checks, preventive maintenance verification, and equipment log integration.
Raw material verification with barcode scanning, material dispensing, batch genealogy, and full material reconciliation.
Multi-level approvals with digital signatures, reviewer comments, and 21 CFR Part 11 compliant approval workflows.
Live manufacturing status, batch progress tracking, process parameter monitoring, and a unified production dashboard.
Complete activity history with user tracking, date/time stamps, and full regulatory audit support.
A documented, GMP-compliant workflow that ensures consistent execution and regulatory compliance across every batch production cycle.
Create and maintain approved master manufacturing templates with standardized instructions and process parameters.
Generate a new batch record by automatically populating data from the approved master batch record.
Record and verify raw material dispensing with traceability to approved material lots and quantities.
Ensure equipment is qualified, calibrated, clean, and approved before manufacturing begins.
Capture and verify material weighing data with electronic checks for accuracy and compliance.
Document every manufacturing step with real-time process data, operator actions, and timestamps.
Record quality checks and process parameters to ensure manufacturing remains within approved limits.
Automatically calculate theoretical and actual yields to identify production variances.
Reconcile material usage, wastage, and remaining inventory to ensure complete accountability.
Log, investigate, and route deviations through the approved quality workflow whenever exceptions occur.
Enable Quality Assurance to review the complete electronic batch record for accuracy, completeness, and compliance.
Apply secure, compliant electronic signatures to authorize manufacturing and quality activities.
Approve and release the batch for distribution after successful completion of all quality requirements.
Generate comprehensive reports and maintain a complete, tamper-evident audit trail of every record and action.
Each step is documented electronically with date/time stamps, user identification, and complete audit trail for regulatory compliance.
Zentixs BMR connects with your existing systems — ERP, LIMS, QMS, and more — for a unified manufacturing ecosystem.
Reliable, secure, and efficient compliance management for regulated industries.
FDA electronic records & signatures standard for pharmaceutical manufacturing.
European GMP guidelines for computerised systems used in pharmaceutical manufacturing.
ISPE framework for risk-based validation of computerised pharmaceutical systems.
Good Manufacturing Practice standards ensuring consistent quality in pharmaceutical production.
World Health Organisation's Good Manufacturing Practice guidelines for medicines.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, and more.
Pharmaceutical Inspection Co-operation Scheme — harmonised GMP standards globally.
UK Medicines & Healthcare products Regulatory Agency data integrity guidance.
FDA electronic records & signatures standard for pharmaceutical manufacturing.
European GMP guidelines for computerised systems used in pharmaceutical manufacturing.
ISPE framework for risk-based validation of computerised pharmaceutical systems.
Good Manufacturing Practice standards ensuring consistent quality in pharmaceutical production.
World Health Organisation's Good Manufacturing Practice guidelines for medicines.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, and more.
Pharmaceutical Inspection Co-operation Scheme — harmonised GMP standards globally.
UK Medicines & Healthcare products Regulatory Agency data integrity guidance.