AmpleLogic QMS Software Modules

In pharmaceutical manufacturing and other highly regulated industries, maintaining quality and compliance is essential. A Quality Management System (QMS) helps organizations streamline processes, improve efficiency, and ensure adherence to regulatory standards like FDA, ISO, and MHRA. Without a well-structured QMS, companies risk non-compliance, inefficiencies, and potential regulatory penalties.

AmpleLogic’s QMS software is specifically designed to address the unique challenges of pharmaceutical manufacturing. With hands-on industry experience, we understand the complexities of managing quality processes. Our QMS provides an integrated approach with powerful modules for document control, change management, deviation handling, CAPA, training management, and more.

By automating workflows and ensuring real-time visibility, AmpleLogic’s QMS helps organizations enhance productivity and maintain a culture of continuous improvement. Whether you are looking to improve compliance, reduce manual efforts, or streamline audits, our robust QMS solution ensures seamless quality management tailored to your industry’s needs.

CAPA Management

Tracks, analyzes, and resolves quality issues while ensuring compliance through structured corrective and preventive actions for continuous process improvement

Change Management

Streamlines change requests, approvals, and impact assessments while ensuring compliance, risk mitigation, and seamless system change implementation

Complaints Management

Tracks, investigates, and resolves customer complaints, ensuring compliance, improving product quality, and enhancing customer satisfaction

Deviation Management

Tracks, investigates, and resolves process deviations while ensuring compliance and continuous quality improvement in regulated industries

Audit Management

Streamlines audit planning, execution, and reporting while ensuring compliance, mitigating risks, and driving continuous quality improvement across industries

Vendor Management

Enhances vendor evaluation, compliance tracking, and performance monitoring to ensure quality, risk mitigation, and strong supplier relationships

Out of Specification

Manages out-of-specification results with automation, compliance tracking, risk assessment, and seamless collaboration for regulatory adherence

Out of Trend

Manages out-of-trend results with automation, rapid investigations, seamless integration, and compliance tracking to enhance quality control efficiency

Incident Reporting

Enables efficient reporting, assessment, and resolution of incidents while ensuring compliance, safety, and continuous improvement in regulated industries

Frequently Ask Questions

1. What is AmpleLogic QMS software?

AmpleLogic’s eQMS is a cloud-based solution for the pharmaceutical and biotech sectors, ensuring compliance with FDA 21 CFR Part 11 and EU Annex 11. It automates quality processes like document control and audits, enhancing efficiency and reducing errors.

2. How does CAPA management software help in quality improvement?

The CAPA module identifies and resolves quality issues through root cause analysis and action tracking, integrating with Deviation and Audit Management to ensure compliance and prevent recurrence

3. What is Change Control Management, and why is it essential?

This module provides a structured workflow for managing change requests, ensuring minimal disruption and compliance with quality standards like GMP

4. How does Market Complaints Management improve customer satisfaction?

It centralizes complaint handling, enabling real-time tracking and trend analysis, which enhances product quality and maintains compliance with FDA and EMA standards.

5. What is Deviation Management?

The Deviation Management module documents and investigates process deviations, facilitating root cause analysis and corrective actions to ensure ongoing compliance.

6. How does Audit Management streamline compliance?

AmpleLogic’s Audit Management automates the audit lifecycle, ensuring adherence to regulations like ISO 9001, with real-time dashboards for improved compliance tracking.

7. Why is Vendor Management important in a QMS?

It evaluates and monitors suppliers for GxP compliance, providing risk assessments and performance tracking to enhance supply chain quality.

8. Can QMS software integrate with other enterprise systems?

Yes, AmpleLogic’s eQMS integrates with systems like LIMS, DMS, and others to ensure data consistency and streamline workflows.

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