AmpleLogic APQR

Annual Product Quality Review System (PQR/APQR)

First AI Infused Solution for Quality Assurance & Regulatory Compliance

Be Audit Ready Always with AmpleLogic AI-Powered APQR

Annual Product Quality Review (APQR) is a mandatory regulatory requirement in the pharmaceutical industry that ensures consistent product quality, robust process control, and continuous compliance with global regulatory standards such as FDA, EMA, and ICH guidelines. However, conventional APQR processes are often fragmented, time-consuming, and highly dependent on manual data collection, static statistical tools, and disconnected systems. This leads to extended review timelines, increased rework, limited data-driven insights, and elevated compliance and audit risks.

AmpleLogic’s Electronic APQR & CPV Solution addresses these challenges by converting traditional APQR into a centralized, automated, and inspection-ready digital quality management workflow. The platform seamlessly integrates data from LIMS, ERP, QMS, and other enterprise systems, creating a single, reliable source of truth for product quality reviews. Automated statistical analysis, dynamic control charts, and end-to-end traceability eliminate manual charting, reduce errors, and ensure data integrity and reproducibility.

Designed with regulatory compliance at its foundation, AmpleLogic APQR enables comprehensive APQR lifecycle management, covering data ingestion, trend analysis, deviation review, CAPA tracking, and electronic approvals. Built-in CPV monitoring, AI-driven summaries, and configurable dashboards allow quality teams to shift focus from manual report preparation to proactive risk management, continuous process improvement, and faster, evidence-based decision-making.

Supporting multi-site pharmaceutical operations with harmonized global templates and audit-ready documentation, AmpleLogic APQR helps organizations reduce APQR review timelines by up to 85%, improve inspection readiness, strengthen compliance posture, and gain real-time visibility into product and process performance across the enterprise.

Commitment to AI-Powered Excellence

Generate Reports Anytime

Generate APQR and PQR reports on demand using predefined, configurable templates with automated data population and analytics.

Continued Process Verification (CPV)

Enable continuous, automated monitoring of critical process and quality parameters across the manufacturing lifecycle with built-in statistical analysis and alerts.

OCR Data Extraction & AI Chatbot

Automatically extract quality data from physical documents, scanned records, and PDFs using OCR, and instantly access APQR and CPV insights through an AI-powered chatbot.

Challenges in Pharma Product Quality Review (PQR) Process

Fragmented Data Collection and Integration

Quality data is spread across LIMS, ERP, QMS, spreadsheets, and paper records, making data aggregation slow, manual, and error-prone, especially in multi-site and legacy environments.

Data Accuracy and Consistency Issues

Manual data transfers, repeated file copies, and static charting increase the risk of inconsistencies, version mismatches, and formatting errors that impact review quality and compliance.

Regulatory Compliance Pressure

Evolving regulatory expectations from global authorities demand complete traceability, reproducible analytics, and inspection-ready documentation, which are difficult to maintain with manual PQR processes.

Limited Analytical and Trending Capabilities

Traditional PQR approaches lack advanced statistical analysis, live control charts, and cross-product trending, delaying risk identification and proactive quality improvements.

Inefficient Cross-Functional Collaboration

Disconnected workflows across manufacturing, QA, QC, and regulatory teams cause delays, poor visibility into actions, and inconsistent communication during the PQR lifecycle.

Features of AmpleLogic APQR

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Audit Preparedness
Ensure inspection readiness with accurate, compliant APQR, PQR, and Continued Process Verification (CPV) reports supported by traceable data, version history, and audit trails.
Instant PQR Report Generation
Generate APQR and PQR reports on demand based on selected review periods using standardized, configurable templates.
Six-Pack Report Generation
Automatically generate six-pack reports using 3 Sigma and 6 Sigma performance indices for robust process capability evaluation.
Master Data Management
Maintain centralized master data for all quality and process parameters, including limits such as NLT, NMT, Min, Max, Equal To, Descriptive, and Report Value.
Seamless System Integration
Integrates seamlessly with LMS, QMS, DMS, MES, and eBMR systems to ensure complete, end-to-end quality data capture.
OCR-Based Data Extraction
Digitize data from physical documents, scanned records, and PDFs using OCR to accelerate PQR generation, improve data accuracy, and enhance audit readiness.
Integrated AI Chatbot
Leverage an AI-powered chatbot to instantly retrieve data from APQR reports and connected systems, supporting faster reviews and smooth audit interactions.
Statistical and Trend Analysis
Perform automated statistical analysis and trending across analytical data, stability studies, yields, critical process parameters, in-process quality parameters, and other APQR-required datasets.
Batch-Wise Trend Reporting
Generate batch-wise trend reports to monitor granulation, compression, coating, and packing yields across the review period.
Golden Batch Facilitation
Support Golden Batch identification by analyzing historical performance and enabling consistent replication of optimal manufacturing conditions.
Continued Process Verification (CPV)
Enable continuous monitoring of critical quality and process parameters with automated statistical evaluation to support ongoing compliance.
Process Capability and Improvement Analysis
Automatically calculate Cp, Cpk, CPU, CPL, UCL, LCL, and standard deviations using embedded R tools and R Studio for deeper process analysis and improvement.
CPP and CQA Monitoring
Track Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using control charts and capability analysis.
OOT and OOS Identification
Detect Out-of-Trend (OOT) and Out-of-Specification (OOS) conditions through systematic analysis of production and quality data.
Advanced Control Charts
Generate I Charts, Normal Probability Plots, Moving Range Charts, and Process Capability analyses, displaying the last 15 observations to assess batch-to-batch variation.
Analytical Method Validation Support
Ensure analytical method reliability with automated calculation of mean, median, and standard deviation values.
Configurable APQR / PQR Templates
Customize APQR and PQR templates to align with site-specific SOPs, regional regulatory expectations, and market requirements.
Integrated Analytical Functionality
Eliminate dependency on external statistical tools such as Minitab, SAS, or SPSS through built-in analytics and reporting.
Manual BMR Data Extraction via OCR
Extract data from manual BMR templates using OCR and seamlessly import it into the APQR system.
Automated Data Collection and Analysis
Automate data collection from source systems to reduce manual effort, minimize errors, and streamline large-scale analysis.
Automatic Version Control
Enable automatic versioning of APQR and PQR documents to maintain traceability and compliance.
Cross-Functional Collaboration
Facilitate collaboration across Manufacturing, QA, QC, and Regulatory teams through shared workflows and visibility.
Auto Alerts and Warnings
Trigger automated alerts for review delays beyond seven days and warnings for deviations, OOS, and OOT scenarios.
Centralized Monitoring of Critical Control Points (CCP)
Define tolerance limits for CCPs and automatically escalate excursions beyond Proven Acceptable Range (PAR) or Normal Operating Range (NOR).
Automated Product Quality Review Execution
Streamline the entire APQR process through automation, reducing manual effort while improving compliance and efficiency.
Nelson Rule Implementation
Apply Nelson’s Rules to detect non-random patterns and out-of-control conditions, strengthening CPV reporting.
CPK Assessment with Visual Indicators
Provide color-coded Cpk indicators to quickly assess process capability and identify areas requiring attention.
Process Parameter Comparison Reports
Generate graphical comparisons of process parameters to evaluate the impact of CAPA actions, vendor changes, or process improvements.
Real-Time Release Testing (RTRT) Enablement
Support Real-Time Release Testing through CPV-driven insights, enabling a shift from traditional end-product testing.
Global Regulatory Compliance
Ensure compliance with 21 CFR Part 11, EU Annex 11, MHRA, and electronic record regulations across global authorities including CDSCO, TGA, Health Canada, ANVISA, SFDA, and others.

Why AmpleLogic’s APQR?

AmpleLogic’s AI-powered APQR solution is purpose-built for pharmaceutical companies, API manufacturers, CDMOs, Biotech, Biosciences, and CROs. This advanced SaaS-based platform is designed in alignment with US FDA and GMP requirements and complies with ICH Q7 (Section 2.5), which mandates periodic quality reviews of APIs, referred to as Product Quality Reviews (PQRs) under EU GMP guidelines.

The solution streamlines PQR generation through intelligent analytics, end-to-end process tracking, and dynamic data visualization to support regulatory compliance, operational efficiency, and quality oversight. It enables continuous monitoring of Critical Control Points (CCPs) with automated alerts for deviations beyond Proven Acceptable Range (PAR) and outside Normal Operating Range (NOR). Quality teams can easily generate detailed three-sigma and six-sigma reports with real-time notifications, ensuring consistent compliance, faster decision-making, and sustained product quality.

Bharat Serums leverages AmpleLogic’s APQR to streamline compliance and enhance regulatory readiness.

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Articles

How You Can Automate Batch Release in APQR?

Is your batch release process still a manual task of checklists, paper trails, and follow-up emails? You’re not alone. Releasing a pharmaceutical batch is one

Automated Batch Release with Amplelogic’s PQR Software

Batch release is one of the most scrutinized stages in pharmaceutical manufacturing. It is a regulated step that requires every manufacturing detail to be documented,

How Can APQR Data Be Used For Continuous Process Verification?

Maintaining constant product quality is of extreme importance in the pharmaceutical sector. A thorough assessment of a product’s quality over the course of the year

What is the primary purpose of AmpleLogic APQR?

AmpleLogic APQR is designed to streamline the Annual Product Quality Review process, ensuring compliance, and providing detailed insights into product quality trends.

How does the software handle deviations?

The software triggers immediate alerts for deviations, allowing timely corrective actions to maintain product quality.

Does AmpleLogic offer SaaS PQR or APQR software?

Yes, AmpleLogic offers SaaS (Software as a Service) APQR software specifically designed for the pharmaceutical industry. Our SaaS solution provides a flexible, subscription-based model with automatic updates, ensuring you have access to the latest features and compliance tools at all times. Accessible from anywhere, our software integrates seamlessly with your existing systems, helping you manage product quality reviews efficiently and reduce manual efforts.

Can AmpleLogic APQR integrate with existing systems?

Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, LIMS, Stability, SAP(ERP), DMS and MES/eBMR for comprehensive data capture.

What statistical analysis does the software perform?

The software conducts statistical analysis on multiple parameters to generate trend charts, control charts, process capability index reports, and Nelson’s rules reports.

Is AmpleLogic APQR compliant with industry standards?

Yes, AmpleLogic APQR complies with major standards including 21 CFR PART 11, MHRA, EU Annex 11, etc ensuring regulatory adherence.

What is Annual Product Quality Review in Pharma?

The Annual Product Quality Review (APQR) in pharma is a yearly assessment of a product’s quality. It involves reviewing data from manufacturing, quality control, and any issues that arose during the year. The goal is to ensure the product meets quality standards, identify trends, and make improvements, helping to maintain product integrity and comply with regulations.

What is GMP Product Quality Review?

Pharmaceutical product quality is evaluated systematically in compliance with Good Manufacturing Practices (GMP) through the Product Quality Review (PQR). It involves checking production and quality control information, like records of how products were made, test results, and any problems or complaints that came up. The PQR is used to make sure that products continuously fulfill quality standards, pinpoint areas that need improvement, and guarantee that regulations are followed. This review aids in preserving the general quality, effectiveness, and safety of the product throughout the manufacturing process.

Do you offer cloud-based APQR software?

Yes, we offer cloud-based APQR software tailored for the pharmaceutical industry. It enables seamless management of Annual Product Quality Reviews from anywhere, featuring automated report generation, regulatory compliance tools, and secure data storage for enhanced collaboration and accessibility.

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