AmpleLogic APQR

Annual Product Quality Review Software

Unlock Quality Excellence with AmpleLogic APQR Software

Unleash Compliance Confidence with AmpleLogic APQR

AmpleLogic APQR revolutionizes Product Quality Reviews, ensuring effortless compliance with auto-generated detailed reports and alerts for delays. Seamlessly integrating with multiple software systems, it provides statistical analysis, trends, performance indices and insightful dashboards for unparalleled quality control.

Generate Reports Anytime

Get quality review reports anytime based on predefined templates

Enhanced Transparency

Efficient visibility of data and authorized verification

Real-time Alerts

Provides auto alerts for delays beyond seven days, ensuring timely actions

Comprehensive Integration

Seamlessly integrates with LMS, QMS, BMS, and MES/eBMR, ensuring holistic data capture.

LIMS

Why Choose AmpleLogic APQR?

Elevate your quality management with AmpleLogic APQR. Gain a competitive edge through automated report generation, real-time alerts, and seamless integration. The software’s statistical analysis and trend insights empower informed decision-making, ensuring compliance and consistent product quality.

Continuous Process
Verification

Implement continuous process verification through six-pack reports and Nelson's rule for robust quality assurance

Regulatory Compliance

Adhere to major standards including 21 CFR PART 11, MHRA, and EU Annex 11, etc ensuring regulatory compliance

Updated Report Templates

Effortlessly generate APQR documents based on predefined templates, saving time and ensuring consistency

Process Capability Analysis

Utilize Process Capability Indices - Cp, CPK, CPU, CPL for in-depth process analysis and improvement

Transform Quality Assurance
with AmpleLogic APQR

Instant Report Generation

Get quality review reports anytime based on predefined templates

Auto-Alerts & Warnings

Provides auto alerts for delays beyond seven days and warnings for out-of-specification scenarios and deviations

Seamless Integration

Integrates perfectly with all LMS, QMS, BMS, and MES/eBMR systems for holistic data capture

Process Improvement

Utilize Process Capability Indices - Cp, CPK, CPU, CPL for in-depth process analysis and improvement

Statistical and Trend Analysis

Provides statistical and trend analysis using R tools for representing efficiency in processes

Auto Versioning

Automatically version PQR documents, maintaining accurate records for compliance

Generate Six-Pack Report

Generate 3 Sigma and 6 Sigma report using performance indices like Cp, Cpk, Pp, Ppk

Analytical Method Validation

Ensure the accuracy of analytical methods with automated calculation of Mean, Median, and Standard Deviations.

Golden Batch Facilitation

Supports “Golden Batch” by identifying and replicating optimal manufacturing conditions consistently

Automated Data Collection and Analysis

Automate the data collection process, reducing manual errors and streamlining the analysis of vast datasets

Cross-Functional Department Collaboration

Helps departments collaborate and enhances communication for streamlining processes

Continued Process Verification (CPV)

Continuous monitoring of critical parameters throughout the manufacturing process for compliance and quality assurance

Determine CPP & CQA

Track critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts

Centralized Monitoring of Critical Control Points (CCP)

Establish tolerance for Critical Control Points (CCP) and escalate any excursions beyond Proven Acceptable Range (PAR) or outside Normal Operating Range (NOR)

Regulatory Compliance

Built-in compliance features like e-signatures, audit trials as required by 21 CFR Part 11 and EU Annexure 11 for ensuring PQR process adheres to latest regulatory requirements

Integrated Analytical Functionality

Integrates comprehensive analytical functionalities, eliminating the need for external tools like SAS, MiniTab, or SPSS, ensuring a seamless and efficient APQR experience

Articles

Frequently Asked Questions

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

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

Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, and MES/eBMR for comprehensive data capture.

The software performs statistical analysis on parameters such as Assay, Water Content, PH, Specific Impurities, and Total Impurities providing valuable insights.

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

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3

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