AmpleLogic OOS: Precision in Quality Assurance
AmpleLogic OOS Software ensures precise management of out-of-specification results, guaranteeing systematic and compliant laboratory investigations. It streamlines preliminary lab investigations with customizable checklists and automates reporting, data capturing, and routing for detailed phase-wise analysis. This cloud-based solution facilitates seamless collaboration among cross-functional teams across departments and regions, enhancing workflow efficiency and information exchange.
Integrated with CAPA/Change Control, APQR, and LIMS, AmpleLogic OOS includes embedded risk assessment and customer communication features. It provides automated alerts and comprehensive reports for timely communication and performance visibility, ensuring regulatory compliance with standards like 21 CFR Part 11. Tailored for pharmaceuticals, biotechnology, commercial testing laboratories, and medical devices industries, this solution empowers organizations to effectively manage out-of-specification results, maintain quality standards, and meet regulatory requirements effortlessly
Features Empowering OOS Management
Simplified Reporting
Automate data capturing and routing for efficient OOS description and inspection.
Phase-wise Investigation
Initiate, evaluate, and monitor investigations seamlessly across departments.
Integrated Quality Systems
Seamlessly integrate with CAPA Management for enhanced information exchange.
Automated Alerts
Receive timely notifications and escalations for impending tasks and overdue activities.
Comprehensive Reports
Access up-to-date summary reports and metrics for performance visibility.
Maximize Efficiency with AmpleLogic OOS
Streamline processes for smoother operations and quicker resolutions.
Enhance assurance through meticulous monitoring and comprehensive reporting.
Prompt alerts for overdue tasks ensure swift problem-solving.
Easily integrate with existing systems for enhanced functionality.
Frequently Asked Questions
What regulatory standards does AmpleLogic OOS comply with?
AmpleLogic OOS is fully compliant with regulations such as 21 CFR Part 11 and various global standards.
How does AmpleLogic OOS streamline investigations?
It automates phase-wise investigations, task assignments, and communication, enhancing efficiency.
Can AmpleLogic OOS integrate with existing quality systems?
Yes, it seamlessly integrates with CAPA Management for improved information exchange.
How does AmpleLogic OOS ensure timely issue resolution?
It provides automated alerts and notifications for impending tasks and overdue activities.
What industries can benefit from AmpleLogic OOS?
AmpleLogic OOS caters to pharmaceuticals, biotech, medical devices, and various other sectors requiring quality control.
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