Software Product

^ZHQualiFly^®excels in performance, is user-friendly, facilitates smoother multi-party communication, while improving the Quality Management System and reducing compliance risks.

Product Advantages:

Compliance with regulatory requirements: Developed by experienced QA personnel in collaboration with pharmaceutical development staff, fully compliant with GXP regulations and 21 CFR Part 11 requirements.

Meeting diverse customer needs: Operational configuration, perfectly tailored to existing processes; site distribution, supporting multi-site group company usage.

High efficiency: Designed to align with end-user work habits, featuring reasonable categorization and powerful search functions to enhance end-user work efficacy.

Improvement of the Quality Management System: Various reminder functions to prevent excursions; combined with big data statistics, supports users in conducting quality trend analysis to improve the Quality Management System.

Preparedness for authority inspections: Detailed audit and investigation information, organized documentation, and robust search functions enable you to handle various audits and investigations with ease.

Support for mobile use: Web login, compatible with tablet usage. Users can access the software anytime from offices, laboratories, and other locations.

Functional Features:

Autonomous configuration of multiple role permissions

Supports users in autonomously configuring various role permissions, closely aligning with existing workflows. Account password strength and safety meet industry requirements.

Integration of tasks and calendar

Task plans are displayed not only in list format but also bound to the calendar. End users can conveniently view their daily work tasks during their daily operations.

Important events at a glance

The homepage displays important matters and significant findings to draw attention from multiple parties. Users can prioritize handling these events.

Autonomous configuration of various templates

Users can set templates based on existing workflows and forms, including but not limited to problem types, inspection checklists, declaration content, etc.

Audit/inspection reports, responses, and review processes are concise and efficient

Records every report, response, and review process. Supports uploading rectification evidence and appendices. Supports adding remarks and personnel updates.

Various reminder functions

Supports task reminders, response reminders, rectification deadline reminders, etc. Reminders include internal system and external (email) notifications.

Email binding

Supports binding of internal and external system emails. Users can receive the latest information from system-generated emails without logging into the system.

Data statistics

Users can classify and analyze generated data to create reports and trend analysis charts.

Electronic archiving

Supports electronic archiving of completed projects. Archived projects cannot be modified and have restricted read permissions.

Electronic Record and Electronic Signature

Fully compliant with 21CFR Part11. Equipped with comprehensive audit trail functionality.