QUALITY SUITE

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

Document Management System (DMS) Features

Document Storage and Organization

A DMS offers a centralized document repository, ensuring that all files are stored in a single, easily accessible location. It supports the creation of structured folder hierarchies and metadata tagging, making document categorization and retrieval more efficient. Additionally, version control and document history features track changes over time, enabling users to access previous versions and maintain accurate records.

Access Control and Security

Security is a core feature of a DMS, with role-based access permissions that restrict document access to authorized personnel. Files are protected through encryption and secure file-sharing mechanisms, ensuring data confidentiality. Audit trails provide a comprehensive record of document activity, allowing organizations to monitor access and ensure compliance with security protocols.

Collaboration and Workflow
Management

The system facilitates collaboration through document approval workflows, streamlining review and approval processes. Annotation and commenting features allow team members to provide feedback directly within the document. Integration with email and third-party tools further enhances productivity by enabling seamless communication and task management.

Search and Retrieval

Advanced search capabilities with metadata filters make it easy to locate specific documents. Optical Character Recognition (OCR) technology allows users to search for text within scanned documents, significantly improving accessibility. The quick preview feature enables users to view document contents without needing to download or open the file.

Compliance and Retention

A DMS supports compliance with industry-specific standards such as ISO and FDA 21 CFR Part 11, ensuring that organizations meet regulatory requirements. Automated retention and deletion policies help manage document lifecycle, preventing the retention of outdated or irrelevant files. Digital signature functionality enables secure and legally binding approvals, further enhancing compliance and efficiency.

Learning Management System (LMS) Features

AI-Enabled Learning

AI revolutionizes learning management by enabling the quick generation of question banks for evaluation purposes. This feature streamlines the learning and assessment process, reducing manual labor while increasing efficiency and accuracy.

Course Management

Effective course management includes tools for creating and organizing courses with ease. The system supports SCORM and xAPI compliance, ensuring seamless integration with various e-learning standards. Additionally, it accommodates multimedia content such as videos, PDFs, and quizzes, enriching the learning experience for users.

User Management

User management in an LMS is facilitated through role-based access, allowing distinct permissions for learners and instructors. It also supports the creation of group assignments and cohort management, promoting collaborative learning. Integration with HR systems ensures seamless user data synchronization and streamlined onboarding.

Progress Tracking and Reporting

Provides detailed learner analytics, enabling instructors to monitor progress effectively. Learners receive completion certificates and transcripts as evidence of their achievements. Real-time progress dashboards offer instant insights into individual and group performance, driving timely interventions.

Interactive Learning

Interactive features such as virtual classrooms and webinars foster real-time engagement. Gamification elements, including badges and leaderboards, motivate learners by adding a competitive edge. Discussion forums and Q&A sections further enhance collaborative learning and knowledge sharing.

Mobile and Offline Access

The LMS is designed with a responsive interface for mobile devices, ensuring learning is accessible anytime, anywhere. Offline access with synchronization capabilities allows users to continue learning even without an active internet connection, syncing their progress once reconnected.

Quality Management System (QMS) Features

Document Control

Document control ensures effective management of quality-related documents through versioning and access control. Automated review and approval workflows enhance efficiency, while a centralized repository simplifies document retrieval and compliance tracking.

CAPA Management

Corrective and Preventive Actions (CAPA) tracking helps organizations address and prevent quality issues. Root cause analysis tools identify underlying problems, and automatic notifications ensure timely task assignments and follow-ups.

Audit and Inspection Management

AmpleLogic QMS streamlines audits with features for scheduling internal and external inspections. It facilitates checklist creation and issue tracking, ensuring thorough evaluations. An audit trail provides transparency and supports regulatory compliance.

Risk Management

Risk management tools enable comprehensive assessment and mitigation strategies. Integration with CAPA ensures proactive measures, while compliance with standards such as ISO 9001 guarantees adherence to industry best practices.

Training Management

The QMS integrates seamlessly with LMS platforms for employee training, ensuring consistent knowledge dissemination. Competency tracking and training records help monitor individual progress, while automated reminders for re-certifications maintain compliance and readiness.

Reporting and Analytics

Reporting features include real-time dashboards for monitoring quality metrics and customizable reports for audits and inspections. Trend analysis tools identify areas for improvement, driving continuous process enhancements.

Hear From Our Customers

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 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 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.

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: