OUT OF TREND SOFTWARE

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AmpleLogic OOT Management Solution

AmpleLogic OOT Software is a comprehensive solution designed to streamline the management of out-of-trend (OOT) results in quality control laboratories. It offers automated reporting, rapid investigation workflows, and seamless integration with existing quality systems, ensuring compliance with regulatory standards and efficient resolution of quality issues.

Efficiency, Compliance, Integration: Key Features

Automated Reporting

Automated Reporting

Streamline OOT reporting process with automated data collection and reporting functionalities.

Rapid Investigations

Rapid Investigations

Accelerate root cause analysis through predefined investigation workflows and automated task assignments.

Seamless Integration

Seamless Integration

Integrate with existing quality management systems for seamless data exchange and workflow coordination.

Compliance Assurance

Compliance Assurance

Ensure adherence to regulatory standards such as FDA guidelines and 21 CFR Part 11 through built-in compliance checks and audit trails.

Customizable Workflows

Customizable Workflows

Tailor workflows to fit specific organizational needs and processes for enhanced flexibility and efficiency.

Real-time Monitoring

Real-time Monitoring

Monitor OOT status and progress in real-time, enabling proactive management and timely interventions.

Automated Alerts and Notifications

Automated Alerts & Notifications

Receive automatic alerts and notifications for pending tasks, approaching deadlines, and critical issues, ensuring timely action.

Configurable Dashboards

Configurable Dashboards

Create customizable dashboards to visualize OOT trends, metrics, and key performance indicators for informed decision-making.

Document Management

Document Management

Centralize document storage and retrieval, ensuring easy access to relevant information during investigations and audits.

Collaborative Platform

Collaborative Platform

Facilitate collaboration among team members by providing a centralized platform for communication, document sharing, and task coordination.

OOT Management Simplified

Streamlined processes and automated workflows reduce manual effort and minimize the time required for OOT investigations, leading to increased productivity and faster resolution of quality issues.

Real-time monitoring and automated alerts enable proactive management of OOT situations, allowing organizations to address issues promptly before they escalate into larger problems.

Access to comprehensive OOT data and customizable dashboards enables informed decision-making based on real-time insights and trends, facilitating continuous improvement initiatives.

Integration with existing quality management systems and document repositories promotes data integrity and ensures a seamless flow of information across the organization, minimizing data silos and improving collaboration.

By reducing manual effort, minimizing errors, and optimizing resource allocation, OOT software helps organizations achieve cost savings in terms of time, labor, and potential product recalls or regulatory fines.

OOT software supports a culture of continuous improvement by facilitating root cause analysis, corrective and preventive actions (CAPA), and post-implementation reviews, driving ongoing optimization of quality control processes.

Hear From Our Customers

Paramita Sarkar
Paramita Sarkar Vice President, OCuSOFT

AmpleLogic understood the limitations we had as a growing organization. With the budget constraints we had, we couldn’t have been able to find a better, flexible and customizable partner than AmpleLogic. We appreciate the team.
Om Prakash Sule
OM Prakash Sule Vice President, Windlas

Windlas Biotech is committed for transparent Quality Management System and other records. "This is the reason we opted for part 11 compliant partner AmpleLogic. Great contribution by AmpleLogic team to make it Live in shortest possible time"
Georges Ibrahim
Georges Ibrahim CQO, Julphar

AmpleLogic’s QMS application has higher level of transparency and efficacy. It has helped us in tracking day to day quality processes to manage huge information and data and also have transparency in managing
complaints.

Frequently Asked Questions

It’s an automated solution for managing out-of-trend results in quality control labs.

By automating reporting, alerts, and integrating with other quality systems.

Yes, it adheres to FDA guidelines and other regulatory standards.

Absolutely, it offers configurable workflows and customizable reports.

Pharmaceutical, biotech, medical devices, chemicals, and more.

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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

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2

Discovery and consultation session 

3

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