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.
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
Hear From Our Customers
Frequently Asked Questions
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.
Can AmpleLogic APQR integrate with existing systems?
Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, and MES/eBMR for comprehensive data capture.
What statistical analysis does the software perform?
The software performs statistical analysis on parameters such as Assay, Water Content, PH, Specific Impurities, and Total Impurities providing valuable insights.
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.
Contact us
Your Pharma Automation Starts Here
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
Your benefits:
- Client-oriented
- Independent
- Competent
- Results-driven
- Problem-solving
- Transparent
What happens next?
1
Schedule a call at your convenience
2
Discovery and consultation session
3
Get your custom proposal