RegionAmpleLogic EMS
Environmental Monitoring System
Ensure Regulatory Compliance and Product Safety
AI-Powered APQR Software
Annual Product Quality Reviews, Reimagined with AI
Annual Product Quality Review is a critical regulatory requirement for pharmaceutical and life sciences organizations. AmpleLogic’s APQR solution enables structured, compliant, and inspection-ready reviews by consolidating quality data, automating trend analysis, and generating audit-ready reports.
Trusted by 100+ Pharma Companies Globally
Heightened Environmental Monitoring for Lifesciences
Environmental Monitoring is critical in the regulated industries for ensuring compliance and product safety. By leveraging advanced functionalities like integrating existing systems, real-time monitoring, and easy tracking, businesses can optimize operations efficiently. Ensuring strict compliance and ensure product integrity using advanced sensors and analytics.
Automated monitoring
Excellent monitoring of the environment for microbial checks
Regulatory Compliance
Meet regulatory standards like US FDA 21 CFR Part 11, EU Annexure 11, etc
Auto Alert System
Real-time alerts for exceeding predefined limits, adherence to sampling frequency and locations specified in SOPs
Easy Tracking
Improved tracking of contamination sources and their addressal
Why choose AmpleLogic EMS?
AmpleLogic Environmental Monitoring Solution stands for its robust features and benefits. Experience real-time environmental monitoring with advanced data tracking and customizable alerts. AmpleLogic’s Pharmaceutical Environmental Monitoring Software solution ensures compliance with regulations, enhances productivity, data integrity and accuracy, saving costs and rendering audit readiness.
Data Tracking & Analysis
Tracks comprehensive data of monitoring activities and provides extensive analysis
Report Generation
Generate real-time reports for quick decision-making and compliance documentation
Intuitive Interface
Intuitive interface for easy navigation and operation
Scalability
Escalate your monitoring capabilities with your growing needs
Superior Environmental Monitoring
Software for Quality Assurance
Automatic Alerts for Exceeding Predefined Limits
Ensures proactive management of environmental conditions with immediate notifications for deviations, enabling swift corrective actions.
Detailed Tracking of Incubation and Observation Data
With incubation, microbial contamination is detected, quantified, and controlled, safeguarding product quality. Keeps track of the entire incubation process used in testing protocols like microbial air sampling, surface sampling, settle plate method, etc.
Integration with Existing Systems
Allows seamless data sharing and compatibility, enhancing overall monitoring efficiency and accuracy.
Real-Time Monitoring and Reporting
Stay always informed about environmental conditions. Generate real-time reports for quick decision-making and compliance documentation.
Contamination Source Identification
Detects and pinpoints the origin of contaminants from HVAC systems, personnel, or external sources, enabling timely intervention to maintain product integrity.
Compliance with Regulatory Standards
Ensures adherence to regulatory requirements and meets FDA and MHRA standards with confidence.
User-Friendly Interface
Simplifies environmental monitoring tasks with an intuitive interface for easy navigation and operation.
Customizable Alerts and Notifications
Tailor alerts to specific needs by setting thresholds and parameters for personalized notifications.
Scalability
Expand and manage increasing volumes of data and additional monitoring stations without compromising system performance.
Data Security and Integrity
Ensures protection and accuracy of collected data while preventing unauthorized access.
Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Life Sciences
Apply Nelson Rules to detect abnormal process behaviour and statistically significant trends.
Pharmaceuticals
Enhance cannabis and tobacco manufacturing with advanced software for efficiency and flexibility.
Medical Devices
Transform the medical device industry with software that enhances compliance.
Gene & Cell Therapy
Address the complexity of advanced therapies by capturing batch-specific data, deviations.
Food & Beverages
Conduct structured product quality reviews that support safety, consistency, and regulatory expectations.
Cosmetics
Boost cosmetics and beauty operations with innovative software for process optimization.
FAQ’s
Get Answers to All Your Queries
Our solution provides automated monitoring, real-time alerts, and comprehensive data tracking to ensure adherence to regulatory standards.
Yes, our solution seamlessly integrates with your current infrastructure, reducing implementation time and costs.
Our solution facilitates easy identification of contamination sources through comprehensive data tracking and analysis.
Yes, our solution is scalable, allowing you to expand monitoring capabilities as your needs evolve.
We implement robust security measures to protect sensitive environmental data, ensuring data integrity and confidentiality.
Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.
