QEdge

QEdge Enterprise Quality Management Software - eQMS is a solution designed to optimize quality processes and ensure regulatory compliance. It caters to companies in industries such as Pharmaceutical, Life Sciences, Biotechnology, API manufacturing, and other sectors where compliance is essential. According to the vendor, this software is utilized by professionals in Quality Assurance/Quality Control, Compliance, Regulatory Affairs, Manufacturing and Operations, and Research and Development to streamline and enhance their quality management activities.

Key Features

Specification Management: According to the vendor, users can create electronic forms as specifications and structure data with controlled and verified values. The software aims to streamline document versions and ensure data security by providing user controls for content access.

Controlled Copy Release (Doc Issuance): The software allows users to manage controlled documents throughout their life cycle, from creation to archiving. According to the vendor, it includes a controlled mechanism for document release to prevent unauthorized access. The system also offers approval procedures and search tools for traceability.

eLearning: The software enables users to manage eLearning sessions and enrollments across multiple locations and departments. According to the vendor, recipients can be assessed with randomly generated quizzes, and data and reports can be exported for tracking and analysis.

Training Records Management: Users can share and manage training data across the company using the software. According to the vendor, the system automatically notifies employees of training requirements and completion. Additionally, it allows users to track training progress against job function requirements and generate training gap reports.

Training Scheduling: The software aims to facilitate easy planning, registration, and follow-up on trainings. Users can monitor and track vendor audits and progress, and design and configure master data for training modules and requirements.

Product Quality (PQR): According to the vendor, the software can automatically generate Product Quality Review (PQR) documents for each manufactured product. Users can monitor and track key data through batch-wise trending reports. The system also aims to ensure compliance and enable integration with other software systems.

Audit Management: The software provides tools to manage and track audits across the organization. Users can create and use checklists for vendor evaluation and audits. According to the vendor, the system allows for generating reports to support decision-making.

Vendor Quality: The software offers features to qualify vendors as per regulatory requirements and manage vendor data and documents. Users can categorize vendors and monitor their audits and progress. The system also aims to track issues and ensure compliance with regulatory standards.

Analytics and AI: According to the vendor, the software allows users to access user-defined custom reports and graphical trending for real-time analysis. It offers a drag-and-drop interface to customize reports without technical knowledge. The system also includes powerful analytics and AI capabilities to convert data into understandable information.

Change Control: The software provides tools for effective change management. Users can manage change requests in a controlled and coordinated manner, and the system can trigger dependent tasks such as impact assessment and risk assessment. According to the vendor, the software offers effectiveness checks that can be set for monitoring in the future.