What is Review by Exception in Pharmaceutical Manufacturing?
Review by Exception is a batch review approach that automatically identifies deviations, missing entries, failed checks, out-of-limit results, incomplete approvals, and other predefined exceptions that require review. Instead of manually reviewing every data point, Quality Assurance teams can focus their attention on records and events that require investigation or quality assessment.
Batch Review & Approval Software is a Designed to support GMP-controlled processes that helps pharmaceutical manufacturers electronically review, verify, approve, and release production batches through standardized quality workflows. It replaces manual batch record reviews, paper documentation, and multiple approval cycles with automated electronic processes that improve accuracy, reduce review time, and strengthen regulatory compliance.
Veritas GxP Batch Review & Approval Software integrates with Electronic Batch Manufacturing Records (eBMR), quality management, material management, and manufacturing operations to provide complete batch visibility, exception management, electronic approvals, and audit-ready documentation. Manufacturers deploy the full module in weeks, not the 6–9 month implementation cycles common with legacy platforms, with built-in support for both US FDA Supports 21 CFR Part 11 requirements and India CDSCO requirements — helping QA teams reduce batch release timelines while ensuring every batch meets quality and regulatory expectations before release.
Simplify Batch Review While Accelerating Batch Release
Comprehensive Electronic Batch Review & Approval
Electronic Batch Record Review
Review complete electronic batch records through a single centralized digital platform, end to end.
Review by Exception
Automatically identify deviations, missing entries, failed checks, and other process exceptions that require QA attention.
Batch Verification
Verify manufacturing steps, material consumption, equipment usage, IPC results, and quality records before approval.
Multi-Level Approval Workflow
Configure reviewer, supervisor, QA, and final release approvals to match your organization's structure.
Electronic Signatures
Approve batch records using secure, 21 CFR Part 11-compliant electronic signatures at every stage.
Exception Management
Track, investigate, and resolve batch review observations before a batch reaches final release.
Automated Notifications
Alert reviewers, approvers, and QA teams of pending activities and overdue approvals automatically.
Batch Release Management
Approve and release finished batches electronically the moment review is successfully completed.
Audit Trail
Maintain complete, tamper-evident traceability of every review, approval, modification, and release action.
Integrated eBMR Connect
Connect directly with Electronic Batch Manufacturing Records (eBMR) for seamless batch execution, review, approval, and release traceability.
Compliance Reporting
Generate audit- and inspection-ready batch review reports for regulators and internal quality reviews alike.
Batch Review & Approval Workflow
Complete Batch Manufacturing
Production finishes all manufacturing steps per the approved master batch record.
Generate Electronic Batch Record
The system compiles the full eBMR automatically from execution data.
Automated Review by Exception
The platform flags deviations, missing entries, and failed checks instantly.
QA Review
Quality Assurance reviews flagged exceptions instead of the entire record line by line.
Investigation of Exceptions
Any flagged deviation is investigated and resolved with documented justification.
Electronic Approval
Reviewers and approvers sign off electronically at each configured workflow stage.
Batch Release Authorization
QA authorizes final release once every approval stage is complete.
Maintain Complete Audit Trail
Automatically record batch review activities, approvals, modifications, exceptions, and release decisions throughout the complete workflow.
Archive Batch Record
The completed record is archived securely for long-term retention.
Archive & Retain Batch Record
Securely archive the completed batch record, supporting documents, approvals, and complete history according to defined record retention requirements.
Accelerate Batch Release Without Compromising Quality
Reduce Batch Review
Automate exception-based review workflows to reduce manual effort and help QA teams complete batch reviews more efficiently.
Improve Product Quality
Ensure every manufacturing record is complete, accurate, and verified before it reaches approval.
Increase QA Productivity
Help QA teams focus their attention on deviations, missing information, failed checks, and other quality-critical exceptions instead of manually reviewing every record.
Eliminate Paper Documentation
Digitize batch review and approval while removing manual, paper-based documentation entirely.
Support GMP Compliance
Maintain inspection-ready electronic batch records with complete, always-current traceability.
Strengthen Data Integrity
Protect batch records with electronic signatures, audit trails, and role-based access controls.
Improve Operational Visibility
Track batch status, pending approvals, and release metrics in real time, across every site.
Reduce Human Errors
Automatically catch incomplete records and workflow exceptions before they reach final release.
Accelerate Product Release
Streamline batch review, exception management, approvals, and release workflows to help reduce delays in the batch release process.
Support Continuous Improvement
Analyze batch review performance and quality trends to drive ongoing process optimization.
Improve Exception Visibility
Provide QA teams with centralized visibility into open exceptions, pending investigations, incomplete records, and approval bottlenecks.
Simplify Batch Release Decisions
Bring relevant batch, quality, approval, and exception information into a structured review process to support informed release decisions.
Built to Support Pharmaceutical Compliance and Data Integrity
Good Manufacturing Practice (GMP)
Digitize batch review and release processes while maintaining complete quality control.
21 CFR Part 11
Support secure electronic records, electronic signatures, and complete audit trails.
India CDSCO
Align batch review and electronic signature workflows with India's Central Drugs Standard Control Organisation requirements.
EU GMP Annex 11
Support controlled electronic workflows, secure records, role-based access, and electronic approvals within validated computerized environments.
ALCOA+ Data Integrity
Ensure batch review records remain attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
Electronic Signatures
Approve batch reviews and releases electronically with secure, verifiable authentication.
Audit Trail
Automatically record every review, approval, modification, and release activity, permanently.
Role-Based Access Control (RBAC)
Ensure only authorized personnel can review, approve, and release production batches.
Purpose-Built Batch Review & Approval for Pharmaceutical Manufacturing
Unlike generic workflow tools adapted for regulated industries, Veritas GxP Batch Review & Approval Software is designed for pharmaceutical manufacturing workflows, connecting electronic batch records, quality processes, exception management, electronic approvals, and batch release within one controlled platform.
Review by Exception Automatically highlight only the quality-critical exceptions that actually need reviewer attention.
Connect Electronic Batch Manufacturing Records, Material Management, Quality Management, deviations, electronic approvals, and batch release processes to maintain traceability throughout the batch lifecycle.
Intelligent Workflow Automation Automate review assignments, approvals, notifications, and release workflows without manual routing.
End-to-End Batch Traceability Track every batch from manufacturing through review, approval, and final product release.
Real-Time Quality Visibility Monitor review progress, approval status, release timelines, and quality KPIs from one dashboard.
Rapid, Dual-Compliant Deployment Go live in weeks with a platform built for both FDA and CDSCO requirements from day one.
Compliance by Design Every review and approval includes electronic signatures, audit trails, and ALCOA+ data integrity controls.
Simplify Your Batch Review and Release Process
Talk to an Expert
+91 9260246321Batch Review & Approval Software enables pharmaceutical manufacturers to electronically review, approve, and release production batches using standardized quality workflows.
Electronic batch review reduces manual review time, improves accuracy, identifies quality exceptions faster, and accelerates batch release.
Review by Exception automatically highlights deviations, incomplete records, failed checks, and quality exceptions so QA teams can focus only on records requiring attention.
Yes. Veritas GxP integrates directly with Electronic Batch Manufacturing Records (eBMR), Material Management, Quality Management, and Electronic Signatures.
Yes. Every review and approval is protected with secure electronic signatures and complete audit trails.
Quality Assurance (QA), Production, Manufacturing, Quality Control (QC), Regulatory Affairs, and Batch Release teams use the solution.
By automating batch review, exception management, approvals, and electronic signatures, Veritas GxP significantly reduces manual effort and speeds up the batch release process.
Veritas GxP supports GMP, 21 CFR Part 11, EU GMP Annex 11, India CDSCO, ALCOA+, electronic signatures, audit trails, and pharmaceutical data integrity requirements.
Batch review involves verifying that manufacturing, packaging, testing, documentation, deviations, and other required activities have been completed according to approved procedures. Batch release is the authorized decision to make a batch available for its intended next stage or distribution after required review and approval activities are complete.
Depending on the organization's procedures, batch review can include manufacturing records, material reconciliation, equipment and process information, in-process checks, laboratory or quality results, deviations, investigations, approvals, and other required batch documentation.
Review by Exception helps QA teams focus on predefined exceptions such as missing entries, failed checks, deviations, incomplete approvals, or other conditions requiring attention instead of manually reviewing every record in the same way.
Yes. Related deviations, investigations, CAPAs, and other quality events can be linked to the batch review process to provide additional context when evaluating the batch before final approval or release.
Electronic batch review centralizes batch records, review activities, approvals, exceptions, and audit history, helping authorized teams retrieve the required information more efficiently during audits and inspections.