AmpleLogic APQR

Annual Product Quality Review Software

Steep Quality Assurance, Maintain Regulatory Compliance

Generate PQR Reports Instantly!

Revolutionize product quality review with AmpleLogic APQR software. Generate detailed three and six sigma reports for regulatory submissions with enhanced real-time alerts. Seamlessly integrated into your operations, APQR adheres to the mandated regulatory standards while providing comprehensive statistical analysis, and insightful dashboards for unparalleled quality control. Attain Continuous Process Improvement with in-depth analysis of processes through statistical representation, trend analysis and performance indices.

Generate Reports Anytime

Get quality review reports anytime based on predefined templates

Real-time Alerts

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

Continued Process Verification (CPV)

Continuous monitoring of critical parameters throughout the manufacturing process

Comprehensive Integration

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

APQR

Why Choose AmpleLogic APQR?

Streamline PQR report generation with AmpleLogic. The software’s insightful statistical and trend analysis representation using R tools aid in informed decision-making. Enhance compliance and ensure consistent product quality with CCP monitoring and excursion escalation beyond PAR and outside NOR.

Three & Six-Pack Report

Generate three and six-pack reports instantly for regulatory submissions

CPP & CQA Monitoring

Maintain Critical Process Parameters and Critical Quality Attributes

Regulatory
Compliance

Adhere to 21 CFR PART 11, MHRA, EU Annex 11, etc

Process Capability Analysis

In-depth process analysis using indices such as Cp, CPK, CPU, CPL

Ace Continuous Improvement of Processes with AmpleLogic APQR

Instant PQR Report Generation

Get quality review reports anytime based on predefined templates

Generate Six-Pack Report

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

Seamless Integration

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

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

Statistical and Trend Analysis

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

Golden Batch Facilitation

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

Continued Process Verification (CPV)

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

Process Improvement

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

Determine CPP & CQA

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

Identify OOT, OOS

Identifies Out-of-Specification (OOS) and Out-of-Trend (OOT) by systematically analyzing production and quality control data

Analytical Method Validation

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

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

Automated Data Collection and Analysis

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

Auto Versioning

Automatically version PQR documents, maintaining accurate records for compliance

Cross-Functional Department Collaboration

Helps departments collaborate and enhances communication for streamlining processes

Auto-Alerts & Warnings

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

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)

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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