AmpleLogic eQMS

Electronic Quality Management Software

Transforming Quality Management for Regulated Industries

Unlock Quality Excellence with AmpleLogic eQMS

AmpleLogic offers a cloud-based eQMS solution tailored for highly regulated industries like Life Sciences, F&B, Beauty & Cosmetics, Medical Devices, Gene Therapy, etc. Our Electronic Quality Management Software tackles industry challenges head-on with transformative deviation management providing real-time insights, excellent system integration and comprehensive CAPA, change control, OOT, OOS modules.

Streamline Quality Management

Excel quality management with proper deviation identification and mitigation

Efficient Documentation

Eliminating manual efforts in document management and tracking

Audit Management

Manage audits efficiently to take informed regulatory decisions

Integration Capabilities

Advanced API integration for streamlined data collection and analysis

Why Choose AmpleLogic eQMS?

In highly regulated environments, choosing the right Quality Management Software (QMS) is crucial. AmpleLogic’s QMS, an ISO 9001 certified cloud-based solution helps you in identifying and tackling deviations using CAPA, Chage Control, OOS & OOT identification and handling, lab incident reporting modules and much more! Navigate complex regulations with AmpleLogic QMS software that ensures quality and compliance.

Regulatory Compliance

AmpleLogic eQMS ensures compliance with global regulations

QMS Modules

A module suite encapsulating CAPA, Change Control, Market Complaints, etc

Data Security

Ensures a secure and compliant environment for critical data assets

Workflow Configuration

Configured to analyse unique business workflows

Unleashing the Power of
AmpleLogic QMS

Discover the robust features that make, AmpleLogic QMS a pinnacle in quality management

Quality Management

Manage quality efficiently with proper analysis and addressal of issues and quality concerns

Manage deviations

Gain insights into the root cause of variances by tracking and analyzing deviations

Risk Mitigation

Mitigate risks effectively under the quality risk management system, ensuring proactive identification and resolution of potential issues

Audit Management

Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance

Visual Insights for Every Module

Access intuitive visual representations to swiftly identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process

Comprehensive Module Suite

Amplify Quality Management with CAPA Tracking, Change Control, Market Complaints, Deviation Management, Audit Management, Vendor Qualification, OOS, OOT and Lab Incident Reporting

Continuous Improvement

Ensures continuous improvement of processes with detailed quality management

Single Signed Access

Access the platform with single sign in enhancing efficiency

Round-the-Clock Accessibility

Web-based application ensures 24x7 end-user access to a secure centralized database

Real time Insights

Track average closure time duration, stay updated on the latest document changes—all through intuitive graphical representations

Enhanced Visibility

Timeline visibility to handle major and minor issues saving resources and time

Activity Closure Timelines

Activity Closure timelines with and without extensions

Maintains Data Security

Data is secure and free from manipulation and loss

Response Time

Quick response time for faster decision making in improving processes

Trend Analysis

Trend analysis for monitoring manufacturing process changes and take risk-based decisions

Pending Task & Viewing History

Get detailed insight on pending tasks with stage wise record and elaborate viewing history

Customization Benefits

Easy customization based on your requirements

Seamless Integration

Easily integrates with MES, DMS, LMS, RIMS, LIMS and ERP systems for streamlined operations

Organogram

Role-based access to fit the hierarchy chart from department to designation to employee profile

Improved Processes

Improved process management and business communication, minimizing user mistakes

Quick Alerts and Prompts

Automatic preemptive alerts, prompts, and escalations for prompt authorization and closure

Reviewed and Verified Processes

All QMS procedures are initiated, approved, assessed, and verified online with electronic signatures and activity stamps

Real-Time Record

Detailed tracking of workflows, processes, modules, and admin-level operations

Built-in Emailing Feature

Enhances communication with customers and regulatory authorities

No Geographical Hindrances

As a web-based solution, AmpleLogic QMS eliminates geographical hindrances

Enhanced Transparency

Web-based access ensures openness and detailed traceability throughout Integrated Quality Systems

Compliant to Global Regulations

Compliant with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc

Modules

Navigating Excellence Through Integrated Modules

AmpleLogic eQMS

CAPA Management Software

Streamline Corrective and Preventive Actions (CAPA) efficiently, ensuring continuous improvement and compliance.

Change Control Management System

Manage changes seamlessly, ensuring controlled modifications to processes, documents, and systems.

Market Complaints Management

Effectively address and manage customer complaints, ensuring swift resolutions and customer satisfaction.

Deviation Management

Identify, document, and manage deviations from standard processes, minimizing risks and ensuring compliance.

Audit Management Software

Facilitate efficient and comprehensive audits, ensuring adherence to regulatory requirements and industry standards.

Vendor Qualification Management

Streamline vendor qualification processes, ensuring only qualified and reliable vendors are part of your supply chain.

Out of Specification

Address and manage situations where product specifications deviate, ensuring product quality and compliance.

Out of Trend

Monitor and manage trends that fall outside expected parameters, ensuring proactive quality management.

Incident Reporting Software

Enable prompt reporting and management of incidents, fostering a proactive approach to quality and safety.

Product Recall

Manage product recalls efficiently, ensuring swift actions to protect consumers and maintain compliance.

Quality Risk Management

Identify, assess, and manage quality risks across processes, products, and systems.

Exploring Deviation Investigation Tools

In the pursuit of operational excellence and quality assurance, deviations from established norms are not just expected but anticipated. However, what truly differentiates successful organizations

Challenges of Change Control in a Regulated Industry

Change control is a critical process in regulated industries, such as pharmaceuticals, medical devices, and food and beverages. It involves managing changes to products, processes,

A Comprehensive Insight on Various Audit Types in Quality Management

Quality audits specifically examine how well product designs and processes meet specified standards and regulatory compliances. They are performed periodically by internal people within the

What is QMS?

A Quality Management System (QMS) is a formalized framework documenting processes, procedures, and responsibilities to achieve quality objectives and ensure compliance with regulatory standards.

How is AmpleLogic’s eQMS Software Tailored for Your Company?

AmpleLogic’s Quality Management Software is highly customizable, allowing companies to implement personalized changes that align with their unique business processes and address specific concerns.

Which Industries Does AmpleLogic’s eQMS Cater To?

AmpleLogic’s eQMS is a top choice for quality management in lifesciences, food & beverages (F&B), beauty & cosmetics, medical devices, and the gene therapy industry.

Does AmpleLogic’s QMS System Comply with International Regulations?

AmpleLogic’s ISO 9001 QMS software adheres to crucial international regulations, including US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, along with Alcoa+ Principles.

What makes AmpleLogic’s eQMS software unique?

We provide customization benefits on all our COTS products including the QMS software. The application has been built keeping in mind the regulatory compliances of various industries around the globe. It provides seamless data and API integration, enhancing transparency and authorization; thereby improving audit quality.

In Which Geographical Areas Do We Offer Our Solutions?

Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.

Your Pharma Automation Starts Here

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: