Deviation Management software

Effortlessly Manage and Mitigate Deviations
for Seamless Operations

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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.

Deviation-Management

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

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)

Root Cause Analysis (RCA)

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

Integration and Connectivity

Integration and Connectivity

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

Remote Accessibility

Accessible 24/7 from anywhere within the company.

Data-Driven Decision Making

Data-Driven Decision Making

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

Automation and Live Tracking

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

Tailored Workflows and Reporting

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

Graphical Representation

Graphical Representation

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

Compliance with Regulatory Standards

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.

Deviation

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

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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2

Discovery and consultation session 

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