Qualityze

Electronic Batch Record (EBR) Management Software

Right-first-time manufacturing starts here. Built for regulated environments, Qualityze helps teams prevent execution errors, reduce deviations, shorten batch release cycles, and improve productivity. Leaders get the real-time visibility across operations, quality, and compliance required to make data-driven decisions and achieve excellence.

Electronic Batch Record (EBR) Management Software

Trusted by quality & compliance teams across regulated industries

LifeMD
Highridge
The Andersons
Prayon
Grynova Consulting Group
Cavin Care
Comply Logo
ZimVie
Scholls Wellness
Care/Of
Kenco Group Client Logo
Garreco Dental Client Logo
Omron Healthcare Client Logo
Ortho8 Client Logo
 Rinchem Co. Inc Client Logo
Cell Signaling Technology Client Logo
Medimaps Group Client Logo
Infinity Molding & Assembly
Monarch Industries Limited Client Logo
Health & Beauty Natural Oils Co. Inc Client Logo
VEM Client Logo
AmeriSave Mortgage Corporation Client Logo
Sparrow Pharmaceuticals Client Logo

End-to-End Batch Record Management

EBR Workflows, Built Around You

Qualityze enables controlled digital batch execution through guided workflows, electronic signatures, audit trails, and built-in process controls that support alignment with global GxP practices.

Closed Loop · AI Insights Feed the Next EBR Workflow · Qualityze Intelligence

Capture, Manage, and Track All Batch Records in One Place for Better Efficiency

Qualityze makes it easy to collect and manage all the important information about batch records, like production data, equipment used, operator details, material lists, key dates, and analysis. All of this is stored in one secure centralized platform. This makes it simple to find what you need, reduces paperwork, makes work more efficient, and ensures no important details are missed.

Record complete batch information in one place

Operational Benefits

One Integrated Platform For Every Role

See how Qualityze helps quality teams to improve the KPIs that matter most, including batch release speed, right-first-time yield, deviation reduction, QA efficiency, productivity, compliance readiness, and manufacturing throughput, to consistently meet expectations for Delivered Quality.

Operations Leaders

Right-First-Time Manufacturing with End-to-End Visibility

VISIBILITY BENEFITS

Controlled execution

Standardize production with guided workflows, enforced checks, and real-time controls.

Enterprise visibility

Track batch progress, exceptions, and production readiness across sites.

Operational Excellence

Reduce deviations, accelerate batch release, and scale production with consistency.

Key Challenges

Where EBR Management Gets Complicated for Quality Leaders

Qualityze transforms batch record management from a compliance obligation into a strategic driver of operational efficiency, manufacturing agility, and business growth.

  • Slow Batch Release Cycles

    Manual review of batch records often delays QA approval and product release,

    Qualityze: Automated batch record workflows and review-by-exception processes with approvals.

  • High Cost of Manual Record Reviews

    Teams spend excessive time reviewing and investigating batch records and getting approvals.

    Qualityze: Standardized workflows, automated checks, and centralized record management.

  • Data Integrity and Compliance Risks

    Manual documentation processes increase the likelihood of missing records, unauthorized changes, and audit observations.

    Qualityze: Enforces role-based access, audit trails, electronic signatures, and compliant record controls.

  • Limited Manufacturing Visibility

    Batch-related information is often scattered across ERP, MES, LIMS, and quality systems, making it difficult to gain a complete view of production performance.

    Qualityze: Helps create a single source of truth for batch execution and review.

  • Inefficient Deviation Management

    Quality events discovered during batch review frequently trigger manual investigations that delay product disposition.

    Qualityze: Links deviations, nonconformances, and investigations to batch records for traceability.

  • Incomplete Product Genealogy and Traceability

    Determining material lineage, affected lots, or manufacturing history can require significant manual effort during audits, complaints, or recalls.

    Qualityze: Maintains complete lot-to-batch traceability by integrating manufacturing, supplier, and quality data.

Cost of Quality

How Qualityze Electronic Batch Record Management Helps You Optimize the Cost of Quality

Replace paper-based processes with a connected EBR platform that reduces errors, accelerates batch release, and strengthens compliance.

Typical cost-of-quality split, Manual Batch Records Managements vs. Closed-Loop EBR Management

Where the money goes

Cost of Reactive Safety— with Manual Batch Records Management

~70% of COQ

Manual data entry and human error, delayed deviation handling, review dependencies, and higher compliance costs

Cost of Proactive Safety — with Qualityze Electronic Batch Record Management

~30% of COQ

Standardized batch execution processes, review by exception, faster batch reviews, and lower costs.
  • Manual Batch Records Management
  • Qualityze Electronic Batch Record Management
Up to 50%
Lower Operational cost
63%+
Faster Batch Review and Release
1 source
of quality truth
  • Guide

    Batch Execution

    Establish standardized batch execution process with validation and verification checks.

  • Prevent

    Manual Errors

    Build stronger process controls for batch review and release without any delays or errors.

  • Review

    Batches Faster

    Enable review by exception and real time visibility for your EBR records.

  • Sustain

    Regulatory Readiness

    Establish repeatable processes for continuous compliance and quality excellence.

System Capabilities

Key Features of the Qualityze Electronic Batch Record Management Solution

Purpose-built for regulated, quality-driven organizations, Qualityze helps quality teams connect batch execution, quality checks, exception management, review, and release in one centralized system.

  • Centralized Batch Record Database

    Track all your Electronic Batch Records in a validated and centralized system with a detailed audit trail for regulatory requirements.

  • Track Historical Data

    Track the data of any record (including the processes involved, verification data, reconciliation data, and much more) using the unique reference number the system assigns to each record.

  • Track Equipment Status

    Track equipment health for due calibrations and maintenance schedules to avoid unnecessary delays, downtime, or incidents.

  • Track Inventory

    Track materials used in production, including quantities, quality, and expiration dates.

  • Perform Line Clearance

    Manage line/room clearance activities with checklists and documentation storage.

  • Track Production Progress

    Track all production steps from order creation to verification, including quality control.

  • Verify Validation and Reconciliation

    Ensure data validation for faster verification and reconciliation of batch quantities and materials used, keeping batch records audit ready.

  • Pre-Defined EBR Form Templates  

    The system comes with pre-defined EBR form templates to collect batch information in a consistent manner.

  • 1 platformSalesforce-native architecture
  • No-code/Low code Configurable to applicable standards
  • Closed-loop EBR Management links to Document, Supplier and Audit

Customer stories

Real Customer Results Delivered by Qualityze

Hear how quality and compliance leaders bring audit planning, execution, and follow-up into one connected process.

Why Choose Qualityze EBR Management?

Achieve right-first-time manufacturing with a cloud-based EBR solution that connects execution, quality, review, and release on one platform.

  • Salesforce-Native Architecture

    Enterprise security, scalability, and stability with SSO, MFA, and role-based access that quality leaders and teams' trust.

  • Truly Closed-Loop

    EBR, Audit, and Nonconformance management share one centralized platform, so you can manage quality and safety events promptly.

  • Compliance You Can Prove

    Validated, 21 CFR Part 11-ready electronic records with electronic signatures and a complete, tamper-evident audit trail for every action.

  • Configurable, No-Code

    Configure workflows, forms and reports to your business and industry specific compliance needs without writing a single line of code.

  • Controlled Manufacturing Execution

    Establish best practices and controls to achieve excellence in manufacturing operations.

  • One Connected Ecosystem

    EBR Management is one pillar of the unified Qualityze suite of enterprise solutions designed for manufacturing excellence.

EBR Management Data Sheet

Get a complete overview of capabilities, deployment, supported standards, and integrations in one downloadable reference.

Everything You Need in an Enterprise-Grade Batch Record Management Solution

The data sheet gives you a quick snapshot of the value you get from Qualityze AI-enabled, cloud-based Batch Record Management System.

  • Configurable EBR Workflows

    Configure EBR workflows based on applicable regulatory requirements.

  • Controlled Batch Execution

    Build EBR workflows with enforced instructions, checks, and electronic signature validation.

  • Right-First-Time Manufacturing

    Prevent errors at the source to reduce deviations and rework for consistent product quality.

  • Faster Review and Release

    Use review-by-exception capabilities to accelerate batch review and release cycles.

  • Support Global Regulatory Frameworks

    Align EBR workflows with applicable regulatory frameworks and industry compliance requirements.

  • Integrate Across the Enterprise

    Connect Batch Record Management to enterprise quality and safety management systems.

FROM THE BLOG

Insights on
Modern Quality

One configurable quality framework that adapts to the compliance demands of every sector — from life sciences to heavy manufacturing.

Frequently Asked Questions

Qualityze Batch Record Management System has features like configurable EBR forms, a centralized batch record database, and inventory management tools. With configurable forms, you can create custom electronic batch records, like Blend Production Records and Process Checklists, to collect consistent data during production. The centralized batch record database keeps all records in one place, making it easy to track and meet regulatory standards.

See Qualityze EBR Management in Action

Discover how our next-generation quality platform can help your team reduce quality costs, resolve issues faster, standardize processes, and drive continuous improvement across your operations.

Qualityze
info@qualityze.com+1-877-207-8616

USA Corporate Headquarters

Qualityze Inc.3903 Northdale Blvd Suite: 100ETampa, FL 33624, USA

UK Regional Office

Qualityze Inc.450 Bath Rd, Longford, Heathrow,West Drayton UB7 0EB, United Kingdom

India Regional Office

Qualityze Solutions Pvt Ltd.No. 27, 1st floor, 80 Feet Ring Rd, 2nd Stage,KHB Colony, Basaveshwar Nagar, Bengaluru,Karnataka 560079, INDIAPhone: +91 96117 58187

2015 – 2026 Qualityze Inc