Qualcy QMS

Qualcy QMS is a Quality Management System specifically designed for bio-medical companies. According to the vendor, this software solution caters to the needs of medical device manufacturers, pharmaceutical companies, and other organizations in the bio-medical industry. It offers features such as document management, calibration and PM management, training record management, CAPA and NCMR management, and audit management.

Key Features

Document Management: According to the vendor, Qualcy QMS provides an easy-to-use document management solution with change control capabilities and designated virtual cabinets. The system ensures that only released and approved documents are accessible to users.

Calibration & PM Management: Qualcy QMS offers comprehensive tracking, review, and approval capabilities for calibration and preventive maintenance activities, according to the vendor. It also allows users to control and manage out-of-tolerance (OOT) conditions effectively.

Training Record Management: The vendor states that Qualcy QMS enables the assignment and tracking of training requirements. Users can evaluate competency requirements and generate reports and metrics to monitor training progress.

CAPA, NCMR, SCAR: According to the vendor, Qualcy QMS streamlines the creation and management of Corrective and Preventive Actions (CAPA), Non-Conforming Material Reports (NCMR), and Supplier Corrective Action Requests (SCAR). The software provides an automated workflow with inbox capabilities for efficient handling of these quality processes.

Audit Management: Qualcy QMS simplifies audit planning, execution, and reporting, as stated by the vendor. Users can create audit plans and schedules, conduct audits, and publish audit reports. The software also offers e-signature and automated workflow functionalities to ensure compliance with ISO and FDA regulations.

User-Friendly: The vendor claims that Qualcy QMS is designed to be user-friendly and easy to implement. It incorporates built-in error-proof mechanisms, role-based identification, and access control for enhanced security. The login process is secure and convenient.

Automated Workflow: According to the vendor, Qualcy QMS enhances visibility and efficiency with its automated workflow capabilities. The software provides an inbox feature for easy visibility of notifications, tasks, and records. Individual task and notification visibility ensure streamlined collaboration.

Full Validation Package: Qualcy QMS includes a comprehensive validation package, which consists of User Requirement Specification (URS), System Requirement Specification (SRS), Trace Matrix, IQ & OQ Reports. The vendor claims that this package ensures full compliance with 21 CFR Part 11 requirements, providing peace of mind to bio-medical companies.

E-Signature Capability: Qualcy QMS offers auditable and traceable e-signatures, according to the vendor. The software allows for the printing of PDFs with time stamps and individual traceability, making documentation and compliance processes more efficient.