21 CFR Part 11 Compliant
Full support for secure electronic signatures, robust audit trails, and strict access controls.
Enterprise grade PQR solution
Elevate Quality.
Ensure Compliance.
Digitize your Annual Product Quality Review (APQR) process. Empower your quality teams with centralized data, automated workflows, and actionable insights.
21 CFR Part 11 Ready
GLP / GCP Compliant
Empowering People with Intelligent Compliance
Product Quality Review is more than a regulatory checkbox—it's an opportunity to optimize your manufacturing consistency. However, manual data aggregation drains your team's valuable time and introduces risk.
Zentixs puts humans back at the center of quality assurance. By automating data collection from LIMS, QMS, ERP, and MES, our platform frees your experts to focus on what matters: analysis, continuous improvement, and patient safety.
Eliminate manual transcription errors
Reduce PQR preparation time by up to 70%
Ensure ALCOA+ data integrity principles
Centralized Data
Consolidate data from LIMS, QMS, ERP, and MES. A single source of truth eliminating manual data collection and errors.
Automated Aggregation
Batch and product-wise data compilation. Automatic trend analysis for critical quality attributes (CQAs).
Performance Review
Review manufacturing process consistency. Analyze yields, deviations, OOS/OOT, and in-process results.
Event Integration
Link Deviations, CAPA, and Change Controls. Track root causes and assess impacts on product quality.
Trend Analysis
Statistical trend charts for quality parameters, stability data evaluation, and process capability analysis.
Stability & Complaints
Integrate stability studies and track market complaints or recalls to rapidly identify adverse trends.
Regulatory Compliance
21 CFR Part 11 compliant. Built-in audit trails, electronic signatures, and data integrity (ALCOA+).
Configurable Workflow
Multi-level review/approval, role-based access, and review cycle automation with smart notifications.
From Raw Data
to Audit-ReadyReport
Everything you need to automate your Annual Product Quality Reviews in one powerful platform.
01
Data Extraction
Automated APIs pull structured data from enterprise systems.
02
Aggregation
Data is normalized and compiled batch-wise into standard templates.
03
Expert Review
Quality teams analyze auto-generated trends, OOS/OOT, and metrics.
04
Final Approval
21 CFR Part 11 compliant digital signatures finalize the PQR.
Product Master & Specification Management
Batch Data Review
Quality Events (Deviation, CAPA, Change Control)
Stability Management Integration
Complaints & Recall Tracking
Trend Analysis & Reporting
Document Management
Workflow & Approval Management
Annual Product Quality Review (APQR) Report
Batch Yield & Trend Reports
Deviation & CAPA Summary
Stability Trend Reports
Complaint Analysis Reports
Process Capability & Variability Reports
Audit Trail & Compliance Reports
Custom Dashboard & KPI Reports
Integrate Across Your Enterprise
Zentixs breaks down data silos by automatically pulling relevant quality and batch data from your existing software ecosystem.
LIMS
Lab Information Management
QMS
Quality Management Systems
ERP
Enterprise Resource Planning
MES
Manufacturing Execution
Built for Global Regulatory Standards
Navigating global pharma regulations is complex. Zentixs is natively engineered to ensure your digital PQR processes meet and exceed the requirements of global regulatory bodies, keeping you inspection-ready at all times.
EU GMP Annex 15 & ICH Q10
Aligns with international guidelines for process validation and pharmaceutical quality systems.
ALCOA+ Data Integrity
Ensuring all aggregated data is Attributable, Legible, Contemporaneous, Original, and Accurate.
Frequently Asked Questions
A Product Quality Review (PQR) is a periodic evaluation of pharmaceutical product quality data. It includes batches, deviations, OOS/OOT results, complaints, CAPA, changes, and stability data to identify trends and improvement areas.
A digital PQR system centralizes data from multiple sources, reduces manual effort, minimizes errors, and improves traceability. It helps teams prepare faster, more consistent, and compliant reviews.
Zentixs PQR manages batch data, deviations, OOS/OOT, CAPA, change controls, complaints, recalls, stability data, and analytical results, all in one place for complete product review.
It consolidates historical data and highlights recurring issues, deviations, and patterns, helping teams quickly detect trends and potential risks.
It provides structured workflows, traceability, controlled access, and complete review history, making audits and inspections easier and more reliable.
Yes. It integrates with LIMS, QMS, manufacturing, and document systems to reduce manual entry and ensure all relevant data flows into the PQR process.