Deviation Management software

Effortlessly Manage and Mitigate Deviations
for Seamless Operations

AmpleLogic Deviation Manager is a comprehensive software solution designed to automate and streamline the deviation management process in the life sciences industry. By leveraging advanced features and customizable workflows, it enables organizations to efficiently report, investigate, and resolve deviations, ensuring compliance with regulatory standards such as FDA, 21 CFR part 11, and EU Annex 11. With its intuitive interface and robust capabilities, AmpleLogic Deviation Manager empowers users to make data-driven decisions, improve operational efficiency, and reduce the recurrence of deviations. Experience seamless deviation management with AmpleLogic and elevate your quality management system to new heights.

Key Features

Automated Deviation Management-01

Automated Deviation Management

Handles both intended and unexpected deviations from reporting to closure.

Quality Metrics and Reporting-01

Quality Metrics and Reporting

Allows thorough examination of activities associated with each process, facilitating CAPA implementation.

Flexible Workflow

Customizable workflows with automated email alerts for verification and escalation.

Audit Trail and Compliance-01

Audit Trail and Compliance

Provides a reliable audit trail compliant with regulations such as 21 CFR part 11 and EU Annex 11, with support for e-signatures and data integrity.

Root Cause Analysis (RCA)-01

Root Cause Analysis (RCA)

Facilitates RCA processes with various assessment methods such as fishbone diagrams and 5 why's analysis.

Integration and Connectivity

Integrates with other quality processes and systems like CAPA, Change Control, and Document Management System.

Remote Accessibility-01

Remote Accessibility

Accessible 24/7 from anywhere within the company.

Data-Driven Decision Making-01

Data-Driven Decision Making

Compiles intelligent data to reduce deviation recurrence and improve operational efficiency over time.

Automation and Live Tracking-01

Automation and Live Tracking

Automates alerts, notifications, and live tracking of deviations, reducing manual entries.

Tailored Workflows and Reporting-01

Tailored Workflows and Reporting

Customizable workflows and reports to fit the organization's needs.

Graphical Representation-01

Graphical Representation

Metrics, reports, and trends presented graphically for comprehensive understanding.

Compliance with Regulatory Standards-01

Compliance with Regulatory Standards

Meets electronic record standards defined by various regulatory bodies.

Benefits of AmpleLogic's Deviation Management Software

Helps meet regulatory standards such as FDA, 21 CFR part 11, and EU Annex 11.

Reduces time for deviation closure, accelerates investigative assignments, and improves operational efficiency.

Ensures data integrity and security in compliance with regulatory standards.

Compiles data to identify root causes and prevent future deviations.

Integrates with other quality management systems for streamlined processes.

Provides 24/7 access from anywhere within the organization, promoting efficiency and collaboration.

Frequently Asked Questions

AmpleLogic Deviation Management Software automates deviation reporting and resolution processes for streamlined compliance in the life sciences industry.

AmpleLogic offers customizable workflows with automated alerts and notifications for efficient deviation management.

Yes, AmpleLogic provides comprehensive reporting and graphical representation for informed decision-making based on deviation data.

The process includes initiation and reporting, investigation and root cause analysis, CAPA implementation and tracking, and closure and documentation.

Schedule a consultation today to learn more about implementing AmpleLogic for your organization’s deviation management needs.

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