Digitize Batch Process Records with a secure electronic BPR solution that standardizes process execution, captures real-time process data, ensures regulatory compliance, and provides complete process traceability from initiation to batch closure.
A purpose-built, fully configurable eBPR platform for pharmaceutical manufacturers —
covering every stage from master process record configuration to batch closure.
Paperless process records with real-time electronic data capture, digital process execution, and automatic document generation.
Configure Master Process Records, manage product-wise process instructions with full version control and controlled revisions.
Real-time capture and verification of critical process parameters — temperature, pressure, speed, time, and yield at every step.
Digital equipment clearance, calibration status checks, line clearance verification, and equipment log integration.
Raw material verification with barcode scanning, dispensing records, batch genealogy, and complete material reconciliation.
Multi-level approvals with digital signatures, reviewer comments, and 21 CFR Part 11 compliant workflow at critical process checkpoints.
Electronic capture of IPC results at defined intervals — weight, hardness, assay, moisture content, and process yield calculations.
Complete process activity history with user tracking, timestamp records, change logs, and full regulatory audit support.
A GMP-compliant digital workflow that captures every process activity, parameter, and approval from batch initiation to final closure.
Create a new BPR linked to the approved Master Process Record, assign batch number, and set target process parameters.
Confirm the current MPR version, review process specifications and critical parameters, and obtain electronic authorization.
Digitally verify equipment cleaning, calibration status, line clearance, and readiness of all process equipment before starting.
Scan and verify all raw materials via barcode, record dispensed quantities, and confirm against formula specifications.
Carry out all manufacturing operations — mixing, granulation, drying, sizing, lubrication — recording actual process parameters at each step.
Capture IPC results at defined intervals — weight variation, bulk density, moisture content, blend uniformity, and yield calculations
Operators and supervisors apply 21 CFR Part 11 compliant digital signatures at every critical process checkpoint.
QA team reviews the complete eBPR, verifies parameter compliance, investigates deviations, and issues final batch disposition.
Closed BPR is archived electronically with full process genealogy, traceability, and ready for regulatory inspection.
Zentixs BPR 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.