Quality Management System for the Pharmaceutical Industry "Quality Designer for GxP"

basic information

●Quality management system for the pharmaceutical and medical device industry "Quality Designer for GxP" Operates change management, complaint management, and CAPA management using electronic forms. Ensures data integrity. Enables secondary utilization of information for analysis through centralized management.

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Applications/Examples of results

【Six Usable Business Examples】 - Change Management: Consistently manage progress from application to consideration, implementation, and completion. By implementing changes for multiple products collectively, it can be managed without omissions. - Quality Information: Manage the entire process from reporting to instructions and completion of responses in a unified manner. It includes necessary task management for collaboration with related departments and medical institutions. - Deviation Management: Flexibly respond to operations based on procedures that suit the situation, from the occurrence of deviations to prevention of recurrence. - CAPA Management: Consistently operate "corrective actions" for issues that arise and "preventive actions" for matters that may pose a risk of problems. - Document Management: Operate the registration, revision, and abolition of documents through a workflow. Controlled execution of operations allows for collaboration with other tasks such as training and education. - Training and Education: Manage from planning to reporting. It automatically links during document registration and revision. It allows for unified management of participant reports, ensuring no omissions or delays.