Generica QMS is a platform for managing globally and onsite level Deviations and CAPA management, investigation, Reporting, CAPA management and trends. Generica QMS deviation and CAPA management can be implemented as an independent solution or integrated to quality audits system.

Deviation & CAPA Management in Your Natural Working Environment

The product brings Quality Compliance Audit Management functionality right into users’ natural working environment – MS Word, MS Excel, PDF and email, and increases user productivity while helping to ensure FDA Quality Compliance. Generica QMS includes pre-defined solution and best practice, but it can be customized to the company processes and needs.

Unlike other Quality audit solutions, Generica QMS does not require companies to make expensive shifts into new environments and does not require the employees to turn away from their natural environments in order to use Quality Audit System

Features

To achieve full coverage of Corporate Regulatory Inspection, the following functionality is covered:

• End to end process flow – from the initiation to closing
• Electronic signature CFR 21 part 11
• CAPA management
• Alerts and reminders
• Reporting tools
• Full search, statistic and trends
• Management dashboards & graphs
• Powerful and flexible permissions
• Full audit trail and history
• Users and groups management