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
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)
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.
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?
Schedule a call at your convenience
Discovery and consultation session
Get your custom proposal
