Qualcy eQMS Version 4.1.0

This video provides an in-depth overview of Qualcy eQMS Version 4.1.0, a cloud-based electronic Quality Management System designed specifically for companies in the Medical Device, Pharmaceutical, and Biotech sectors. Presented by Sanjay Dal, a co-founder and group manager for quality and compliance solutions at Qualcy with over 18 years of experience in regulated industries, the video highlights the inefficiencies of traditional paper-based or Excel/Access QMS systems and positions Qualcy eQMS as a modern, compliant alternative. The core purpose is to showcase the software's features, benefits, and modules that streamline quality and compliance operations.

The presentation emphasizes the system's ease of use and built-in compliance features as key differentiators. Hosted on Amazon AWS, Qualcy eQMS offers IQ/OQ validation reports crucial for regulatory adherence. It boasts built-in templates and workflows to reduce manual effort in document creation, along with essential regulatory compliance features like audit trails and e-signature options. The system incorporates automatic workflows for all modules, allowing for flexible setup of review and approval processes, with records securely stored in virtual cabinets. Furthermore, it includes auto-scheduling and reminder functionalities to eliminate manual email notifications for pending tasks or upcoming deadlines.

The video then delves into specific modules, demonstrating their functionalities. The Document Management module supports the full document lifecycle, from drafting to release and archiving, with advanced search capabilities. The Training Management module is integrated with document management, automatically notifying users of updated documents requiring training and tracking assignments and completions. The Equipment Management module provides comprehensive tools for managing equipment, calibration, preventive maintenance (PM), and out-of-tolerance (OOT) events, including IQ/OQ data. Finally, the CAPA (Corrective and Preventive Actions) module showcases a structured workflow for managing investigations, implementations, and effectiveness verifications. Additional modules for Audit Management, NC (Non-Conformance) Management, Supplier Quality Management, and Product Risk Management are also mentioned, highlighting the system's integrated nature.

Key Takeaways:

• Addressing QMS Inefficiencies: The Qualcy eQMS directly tackles the common challenges faced by life sciences companies using outdated paper-based or spreadsheet-driven Quality Management Systems, which often lead to wasted time and resources.
• Cloud-Based and Compliant Platform: The software is a cloud-based solution hosted on Amazon AWS, ensuring accessibility and scalability, while also providing critical IQ/OQ validation reports necessary for regulatory compliance in pharmaceutical, biotech, and medical device industries.
• Robust Regulatory Compliance: A central focus is compliance with stringent industry regulations, including 21 CFR Part 11 for electronic records and signatures, ISO standards, and FDA requirements, featuring built-in audit trails and e-signature capabilities.
• Streamlined Document Management: The system offers a comprehensive document management module that handles the entire document lifecycle, from creation and drafting to review, approval, release, and automatic archiving of previous versions, supported by advanced search functionalities.
• Integrated Training Management: The training module is seamlessly integrated with document management, automatically generating training notifications when documents are updated and providing dashboards to track user assignments and completion metrics.
• Comprehensive Equipment Management: It provides full functionality for managing equipment, including calibration specifications, preventive maintenance schedules, handling of out-of-tolerance events, and the ability to manage Installation Qualification (IQ) and Operational Qualification (OQ) data.
• Structured CAPA Workflow: The CAPA module features a built-in workflow that guides users through the entire corrective and preventive action process, from initial documentation and investigation to implementation and effectiveness verification.
• Automation and Reminders: The eQMS significantly reduces manual administrative tasks through automatic workflow options, auto-scheduling, and reminder notifications for pending tasks, improving efficiency and ensuring timely completion of quality processes.
• User Management and Data Control: The system includes robust user management capabilities, allowing for registration, permission assignment, and the management of static data such as department names and equipment details, ensuring data integrity and controlled access.
• Integrated Quality Modules: Beyond the demonstrated features, Qualcy eQMS offers additional integrated modules for Audit Management, Non-Conformance Management, Supplier Quality Management, and Product Risk Management, providing a holistic approach to quality control.
• Ease of Use and Customization: The software is designed to be simple and easy to use, featuring built-in templates and flexible setup options for workflows, allowing companies to tailor the system to their specific operational requirements without starting from scratch.

Tools/Resources Mentioned:

• Qualcy eQMS software (Version 4.1.0)
• Amazon AWS platform

Key Concepts:

• eQMS (electronic Quality Management System): A software system designed to manage and automate quality processes and documentation in regulated industries.
• 21 CFR Part 11: Regulations issued by the FDA governing electronic records and electronic signatures, ensuring their trustworthiness, reliability, and equivalence to paper records.
• IQ/OQ (Installation Qualification/Operational Qualification): Protocols used in regulated industries to verify that equipment is installed correctly and operates according to specifications.
• GMP (Good Manufacturing Practices): Regulations ensuring that products are consistently produced and controlled according to quality standards appropriate for their intended use.
• GLP (Good Laboratory Practices): A set of principles intended to assure the quality and integrity of non-clinical laboratory studies.
• ISO (International Organization for Standardization): An independent, non-governmental international organization that develops international standards.
• Audit Trails: A chronological record of system activities, including who accessed what data, when, and what changes were made, crucial for regulatory compliance.
• E-signatures: Electronic data that is logically associated with other electronic data and which is used by the signatory to sign the electronic data.
• CAPA (Corrective and Preventive Actions): A system for identifying, documenting, and resolving non-conformances and preventing their recurrence.
• Document Management: The process of managing documents throughout their lifecycle, from creation to archiving.
• Training Management: The process of planning, delivering, and tracking employee training, especially critical for compliance in regulated industries.
• Equipment Management: The systematic management of equipment, including calibration, maintenance, and performance monitoring.
• Risk Management: The process of identifying, assessing, and controlling risks to an organization's operations, products, or services.