AmpleLogic Quality Suite

AmpleLogic Quality Suite encompasses three essential products

AmpleLogic Quality Suite encompasses three essential products i.e., Document Management System, Learning Management System and Quality Management System. All these products seamlessly integrate with one another and with external systems. With our GAMP solution suite, the pharma industry can now streamline operations and comply with quality and regulatory standards.

Our three-pack solution is ideal for regulated industries owing to its regular updates and in-built validation processes. As regulated industries need technological intervention to optimize processes with accuracy, AmpleLogic’s Quality Suite proves unbeatable! The three-pack solution complies with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc. Try AmpleLogic’s comprehensive software suite to ace business process excellence today!


AmpleLogic Quality Suite Modules

CAPA Management Software

Efficiently manage corrective and preventive action processes from initiation to evaluation, ensuring compliance and enhanced quality control with AmpleLogic's CAPA Management module.

Change Control Management System

Streamline automation, ensure compliance, and boost productivity throughout the change management lifecycle with AmpleLogic Change Control software, tailored for GMP-driven industries.

Document Management

Efficiently manage document lifecycle with our integrated Document Management System (DMS). Ensure compliance and streamline processes with version control, document tracking, and secure access controls.

Training Management

Empower your team with our robust Learning Management System (LMS) designed to streamline learning and development processes. Track employee training progress, certifications, and compliance requirements effortlessly.

Market Complaints Management

Streamline complaint intake, investigation, and resolution processes with AmpleLogic's comprehensive software, ensuring compliance and enhancing customer satisfaction in regulated industries.

Deviation Management

Automate and streamline deviation management in the life sciences industry with AmpleLogic Deviation Manager. Ensure compliance with FDA 21 CFR part 11 and EU Annex 11 while enhancing operational efficiency and reducing recurrence.

Audit Management Software

Enhance audit processes for pharmaceutical, biotech, and medical device industries with AmpleLogic's Audit Management Software. Automate planning, execution, reporting, and follow-up to meet GMP audit and compliance requirements.

Vendor Qualification Management

Streamline vendor assessment processes, automate workflows, and ensure compliance with AmpleLogic's Vendor Qualification Management software, enhancing efficiency and quality in pharmaceutical operations.

Out of Specification (OOS)

Ensure compliant management of out-of-specification results with AmpleLogic's OOS Software. Streamline lab investigations, automate reporting, and improve cross-functional collaboration to enhance workflow efficiency.

Out of Trend (OOT)

Manage out-of-trend results in quality control labs efficiently with AmpleLogic's OOT Software. Automate reporting, streamline investigation workflows, and ensure regulatory compliance for swift resolution of quality issues.

Incident Reporting Software

Manage incidents comprehensively with AmpleLogic Lab Incident Reporting (LIR) software. Facilitate efficient reporting, assessment, and resolution of quality events while ensuring regulatory compliance.

Product Recall Management

Efficiently handle product recalls with AmpleLogic's Product Recall Management software. Swiftly identify, assess, and execute recalls while ensuring regulatory compliance and protecting brand reputation.

Quality Risk Management (QRM)

Proactively identify, assess, and mitigate risks with AmpleLogic's QRM solution. Utilize advanced analytics and streamlined workflows to support risk-based decision-making and enhance overall quality performance in regulated industries.


Features of AmpleLogic Quality Suite

AI-Enabled Learning

AI enables quick generation of question banks for evaluation purposes. This enables streamlined learning and assessments with lesser manual labour and more efficiency

Quality Assurance

Streamline operation, and ensure quality and regulatory compliance with advanced CAPA, change control and deviation handling, document management, etc.

Document Comparison

Easily compare changes made between different versions of a document

Streamline Operations

Optimize tedious operations using AmpleLogic’s Quality Suite to ensure accuracy, efficiency, and quality

MS Word Integration

Streamline document creation, editing and management within familiar Word environment

Real-Time Monitoring

Real-time monitoring of data with automated alerts and notifications during escalations and deviations

Training Control

Tailor and control training programs for employees based on their department, designation, and specific job roles to ensure impactful learning experience

Audit & Quality Management

Schedule and track audits, also handle deviations, OOT, OOS, etc using the AmpleLogic QMS system

Documentation Efficiency

Streamline documentation lifecycle of SOPs, STPs, BMRs, reports, etc. with superior system integration, data security, version control, saved documentation templates, etc.

Version Control

Easily update SOPs, STPs, etc. and keep track of all changes in documents to eliminate confusion

Continuous Improvement

AmpleLogic’s Quality Suite enables continuous improvement of processes through risk assessment and mitigation and real-time monitoring

Workflow Configuration

Workflow can be configured to each business's needs, according to their processes and operations

Role-based Access

Access is provided based on role and responsibilities. This includes training and other criteria that might be required for a process

Cross-Functional Department Collaboration

Helps departments collaborate and enhances communication for streamlining processes

Role-Based Training

Personalised training for each employee as per requirement of role and responsibility.

Enhanced Compliance Training

Learn about regulations and SOPs that are ever-evolving in the dynamic realm of life sciences

Bio-Metrics System Integration

Use biometric fingerprint technology to track attendance accurately and securely, allowing tailored training schedules for present employees

Data Analysis and Security

Get advanced data analysis and security with robust encryption, access controls and real-time monitoring features

Seamless Integration

Integrate seamlessly with internal and external systems to collect data, analyze them and provide real-time insights

Single Sign-in

Single sign-on across all systems saves time and effort. It streamlines major processes with faster sign-in and control

Saves Time

Saves a lot of time owing to streamlined processes, single-user sign-in, and lesser manual labour

Regulatory Compliance

Comply with global regulations like US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, etc


Frequently Asked Questions

AmpleLogic APQR is designed to streamline the Annual Product Quality Review process, ensuring compliance, and providing detailed insights into product quality trends.

The software triggers immediate alerts for deviations, allowing timely corrective actions to maintain product quality.

Yes, AmpleLogic APQR seamlessly integrates with various systems, including LMS, QMS, BMS, and MES/eBMR for comprehensive data capture.

The software performs statistical analysis on parameters such as Assay, Water Content, PH, Specific Impurities, and Total Impurities providing valuable insights.

Yes, AmpleLogic APQR complies with major standards including 21 CFR PART 11, MHRA, EU Annex 11, etc ensuring regulatory adherence.

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