React

React is an integrated, specialized Quality Management System designed to manage audits, deviations, events and action plans (CAPA - corrective and preventive actions).
The main features of the system include:

• General Events (such as management decisions and action plans)
• Deviation Management with work flows according to the deviation type (OOS, OOT, MDR, etc)
• External and Internal Audit management
• Customer Complaints
• Change Management
• Workplace Safety
• unified CAPA of all types of events
• Automatic alerts via eMail, SMS, etc.
• Integration with the company Intranet / Portal for easy user interaction
• Support for electronic signatures
• Extensive query and reporting capabilities
• Full 21 CFR Part 11 compliance
• Validation kit included

React has been developed and evolved with the help of our user community and includes the special features required by the Pharmaceutical industry.

React is a critical building block of the organization's Quality Assurance system, both in daily life and in regulatory audits.

Special workflows are predefined to manage the different tasks associated with different types of deviations:

• Manufacturing Deviation
• Quality Control
• Critical Systems
• out of Specifications (OOS)
• Out of Trends (OOT)
• Change Control (CCP)
• Customer Complaints
• Workplace Safety