GAMP-Compliant AI Platform for Life Sciences & Regulated Industries
  • Low-code aPaaS
  • Careers
  • Low-code aPaaS
  • Careers

AI-Powered APQR Software

Annual Product Quality Reviews, Reimagined with AI

Annual Product Quality Review is a critical regulatory requirement for pharmaceutical and life sciences organizations. AmpleLogic’s APQR solution enables structured, compliant, and inspection-ready reviews by consolidating quality data, automating trend analysis, and generating audit-ready reports.

AI-Powered APQR Software

Annual Product Quality Reviews, Reimagined with AI

Annual Product Quality Review is a critical regulatory requirement for pharmaceutical and life sciences organizations. AmpleLogic’s APQR solution enables structured, compliant, and inspection-ready reviews by consolidating quality data, automating trend analysis, and generating audit-ready reports.

Trusted by 100+ Pharma Companies Globally

Built to Support Modern Regulatory Expectations

Centralized APQR Data Collection

Consolidate inputs from deviations, CAPA, complaints, OOS/OOT, stability studies, and manufacturing data into a single, controlled APQR workspace.

Legible, Compliant Records

Ensure standardized formats, controlled data entry, and complete audit trails to support regulatory inspections.

Easy Access for Cross-Functional Teams

Enable quality, manufacturing, laboratory, and regulatory teams to collaborate securely within a single system.

Secure Audit Access

Provide controlled, read-only access to auditors and inspectors with complete traceability and evidence.

Always Inspection-Ready with AmpleLogic APQR

Regulatory inspections demand accurate, complete, and traceable product quality data often with very little notice. Manual APQR processes and disconnected systems make it difficult to retrieve consistent information, respond confidently to auditor questions, and demonstrate control over quality trends.

AmpleLogic APQR provides a structured, system-driven approach that ensures inspection readiness at all times. By centralizing APQR data, enforcing standardized review workflows, and maintaining complete audit trails, organizations can quickly access historical reviews, supporting evidence, and approval records. Built-in controls help ensure data integrity, consistency, and compliance—enabling teams to respond to inspections with confidence rather than urgency.

In regulated environments, inspection readiness is not a one-time activity—it must be continuously maintained. APQR data is often requested across multiple years, products, and sites, requiring organizations to demonstrate not only outcomes but also the decision-making process behind them. Without a centralized system, this becomes reactive, time-consuming, and error-prone. AmpleLogic APQR ensures that every review cycle is documented, approved, and preserved in a controlled manner.

 

All inputs, analyses, conclusions, and corrective actions are linked and traceable, providing a clear audit trail that supports regulatory expectations for transparency and accountability. By standardizing APQR execution and embedding compliance controls into daily operations, organizations can move away from last-minute data gathering and manual reconciliation. Instead, quality and regulatory teams gain continuous visibility into product performance, enabling faster responses to inspection queries and greater confidence in audit outcomes.

Enhancing APQR with Intelligent Automation

Annual Product Quality Reviews involve large volumes of structured and unstructured data from multiple systems and departments.

icon

AI-Assisted Data Analysis

Automatically identify trends, anomalies, and recurring quality issues across review cycles.

icon

OCR-Based Data Capture

Extract relevant data from scanned documents and legacy records to reduce manual effort.

icon

AI-Generated Summaries

Create intelligent summaries of APQR findings to support faster decision-making and approvals.

Key Functional Capabilities

Six-Pack APQR Report Generation

Automatically generate standardized Six-Pack APQR reports by consolidating quality.

Product-wise Trend Analysis

Analyze quality trends across individual batches and entire product portfolios.

Master Data Management Products

Maintain controlled master data for products, manufacturing sites, batches, and quality parameters.

Nelson Rule-Based Statistical Analysis

Apply Nelson Rules to detect abnormal process behaviour and statistically significant trends.

Golden Batch Identification

Identify optimal manufacturing conditions by analyzing historical batch data, helping teams.

Automatic Version Control

Track every change to APQR records, analyses, and reports with complete version control.

Built-In Insights Without External Tools

AmpleLogic APQR includes integrated analytics and dashboards to visualize quality trends, risks, and performance indicators eliminating dependency on external reporting tools.

Request a Demo

APQR Designed for Regulated Manufacturing

AmpleLogic’s APQR solution is purpose-built to support regulated manufacturing environments where product quality, data integrity, and inspection readiness are critical.

Life Sciences

Apply Nelson Rules to detect abnormal process behaviour and statistically significant trends.

Pharmaceuticals

Ensure consistent and inspection-ready APQR execution aligned with regulatory requirements.

Medical Devices

Manage APQRs with controlled documentation, version history, and traceability to support quality system.

Gene & Cell Therapy

Address the complexity of advanced therapies by capturing batch-specific data, deviations.

Food & Beverages

Conduct structured product quality reviews that support safety, consistency, and regulatory expectations.

Cosmetics

Maintain standardized APQR documentation and quality trend visibility to support regulatory.

Case Studies

Why Choose AmpleLogic APQR

AmpleLogic APQR is designed to help regulated organizations conduct Annual Product Quality Reviews with greater confidence, consistency, and efficiency. Built specifically for compliance-driven environments, the solution combines structured workflows, intelligent automation, and scalable architecture to support inspection-ready APQR execution across products and sites.

Purpose-Built for Regulated Environments

Designed to meet regulatory expectations for data integrity, traceability, and audit readiness, AmpleLogic APQR embeds compliance controls.

AI-Enabled Insights for Proactive Quality Management

Leverage intelligent automation to identify trends, anomalies, and recurring quality issues early enabling teams to move from reactive reporting.

Reduced APQR Cycle Time and Manual Effort

Automated data consolidation, analysis, and reporting significantly reduce manual effort, allowing teams to complete APQRs faster.

Scalable Across Products, Sites, and Geographies

Manage APQRs consistently across multiple products, manufacturing sites, and regions through a centralized platform designed to scale.

Our compliance

Why Choose us?

Our compliance-first, AI-enabled platform is designed to meet the rigorous demands of regulated industries, enabling faster application.

Icon

10X Faster Deployment

Our platform accelerates solutions, reaching markets 10x faster.

Icon

ROI in 3 Months

Low-code solutions deliver fast deployment, cost savings, & quick ROI.

Icon

98% Project Rate

Experience a 98% success rate, surpassing the industry average of 56%

Icon

Domain Expertise

We deliver tailored solutions, ensuring business growth and lasting success

FAQ’s

Get Answers to All Your Queries

GAMP stands for Good Automated Manufacturing Practice. It’s a set of guidelines and best practices for the pharmaceutical industry to ensure that automated systems are properly designed, validated, and maintained.

AmpleLogic GAMP Solutions provide compliant digital solutions that help organizations meet regulatory requirements through validated systems and documentation.

Compliance is ensured through validation frameworks, audit trails, documentation, and adherence to global regulatory guidelines.

aPaaS (Application Platform as a Service) enables rapid application development, deployment, and management in a compliant environment.

Key features include compliance-ready workflows, audit trails, validation support, scalability, and enterprise security.

Data integrity is ensured through access controls, encryption, audit logs, and compliance with ALCOA+ principles.