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.
Get quality review reports anytime based on predefined templates
Provides auto alerts for delays beyond seven days, ensuring timely actions
Continuous monitoring of critical parameters throughout the manufacturing process
Integrates with LMS, QMS, BMS, and MES/eBMR for holistic data capture
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.
Generate three and six-pack reports instantly for regulatory submissions
Maintain Critical Process Parameters and Critical Quality Attributes
Adhere to 21 CFR PART 11, MHRA, EU Annex 11, etc
In-depth process analysis using indices such as Cp, CPK, CPU, CPL
Get quality review reports anytime based on predefined templates
Generate 3 Sigma and 6 Sigma report using performance indices like Cp, Cpk, Pp, Ppk
Integrates perfectly with all LMS, QMS, BMS, and MES/eBMR systems for holistic data capture
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
Provides statistical and trend analysis using R tools for representing efficiency in processes
Supports “Golden Batch” by identifying and replicating optimal manufacturing conditions consistently
Continuous monitoring of critical parameters throughout the manufacturing process for compliance and quality assurance
Utilize Process Capability Indices - Cp, CPK, CPU, CPL for in-depth process analysis and improvement
Track critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts
Identifies Out-of-Specification (OOS) and Out-of-Trend (OOT) by systematically analyzing production and quality control data
Ensure the accuracy of analytical methods with automated calculation of Mean, Median, and Standard Deviations
Integrates comprehensive analytical functionalities, eliminating the need for external tools like SAS, MiniTab, or SPSS, ensuring a seamless and efficient APQR experience
Automate the data collection process, reducing manual errors and streamlining the analysis of vast datasets
Automatically version PQR documents, maintaining accurate records for compliance
Helps departments collaborate and enhances communication for streamlining processes
Provides auto alerts for delays beyond seven days and warnings for out-of-specification scenarios and deviations
Establish tolerance for Critical Control Points (CCP) and escalate any excursions beyond Proven Acceptable Range (PAR) or outside Normal Operating Range (NOR)
Competition is exceedingly high within the pharmaceutical and biotechnology industry whereby quality standards are thus reprehended. This requires constant supervision and investigation of processes involved
In today’s fast-paced and highly regulated industries, Product Review software has become an indispensable tool. Evolving from basic tracking systems to sophisticated, integrated platforms, these
In today’s competitive business landscape, maintaining high product quality and continuously improving offerings is essential for success. APR (Annual Product Review) software has emerged as
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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