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Batch Process Record (BPR) Software

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.

Everything You Need for
Electronic Batch Process Records

A purpose-built, fully configurable eBPR platform for pharmaceutical manufacturers —
covering every stage from master process record configuration to batch closure.

Electronic Batch Record (eBMR)

Paperless process records with real-time electronic data capture, digital process execution, and automatic document generation.

PaperlessDigital
Master Process Record (MPR) Management

Configure Master Process Records, manage product-wise process instructions with full version control and controlled revisions.

MPRVersion Control
Process Parameter Monitoring

Real-time capture and verification of critical process parameters — temperature, pressure, speed, time, and yield at every step.

Real-timeYield
Equipment & Line Clearance

Digital equipment clearance, calibration status checks, line clearance verification, and equipment log integration.

CalibrationClearance
Material Dispensing & Reconciliation

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

BarcodeGenealogy
Electronic Signatures

Multi-level approvals with digital signatures, reviewer comments, and 21 CFR Part 11 compliant workflow at critical process checkpoints.

21 CFR Part 11Multi-level
In-Process Controls (IPC)

Electronic capture of IPC results at defined intervals — weight, hardness, assay, moisture content, and process yield calculations.

IPCQC Data
Audit Trail & Traceability

Complete process activity history with user tracking, timestamp records, change logs, and full regulatory audit support.

ALCOA+Regulatory

Batch Process Record Workflow

A GMP-compliant digital workflow that captures every process activity, parameter, and approval from batch initiation to final closure.

01
Initiate Batch Process Record

Create a new BPR linked to the approved Master Process Record, assign batch number, and set target process parameters.

02
Verify Master Process Record

Confirm the current MPR version, review process specifications and critical parameters, and obtain electronic authorization.

03
Equipment & Line Clearance

Digitally verify equipment cleaning, calibration status, line clearance, and readiness of all process equipment before starting.

04
Raw Material Dispensing

Scan and verify all raw materials via barcode, record dispensed quantities, and confirm against formula specifications.

05
Execute Process Steps

Carry out all manufacturing operations — mixing, granulation, drying, sizing, lubrication — recording actual process parameters at each step.

06
Record In-Process Controls

Capture IPC results at defined intervals — weight variation, bulk density, moisture content, blend uniformity, and yield calculations

07
Capture Electronic Signatures

Operators and supervisors apply 21 CFR Part 11 compliant digital signatures at every critical process checkpoint.

08
Review & Approve BPR

QA team reviews the complete eBPR, verifies parameter compliance, investigates deviations, and issues final batch disposition.

09
Close & Archive Batch Process Record

Closed BPR is archived electronically with full process genealogy, traceability, and ready for regulatory inspection.

Key BPR Principles

GMP-Compliant
Full Audit Trail
21 CFR Part 11
Complete Traceability
Real-Time Monitoring
Automated IPC Alerts

Seamless Product Integrations

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

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

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.

Frequently Asked Questions

A Batch Process Record (BPR) documents the complete process execution history of a production batch, including process parameters, equipment used, in-process controls, deviations, and all operator activities and approvals.
Yes. Zentixs BPR is fully designed to support 21 CFR Part 11, EU Annex 11, GMP, GAMP 5, and ALCOA+ data integrity principles for electronic process records.
A Batch Manufacturing Record (BMR) covers the overall manufacturing record including materials, equipment, and steps. A Batch Process Record (BPR) specifically focuses on detailed process parameter capture, real-time process data, IPC results, and step-by-step process execution with parameter verification.
Yes. Zentixs BPR integrates seamlessly with ERP (SAP, Oracle), LIMS, QMS, BMR, MES, SCADA/PLC, WMS, and other manufacturing systems to create a unified data environment.