Generica QMS is used for managing Global Quality Audit processes, including Pharmaceuticals Co-Vigilance Audits. It can be implemented as an end-to-end solution for all of the corporate quality audits or as a standalone solution.

Pharmaceuticals Co-Vigilance Audits 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 Pharmaceuticals Co-Vigilance Audits, the following functionality is covered:

• Yearly/Quarterly audit planning
• Plans Conflicts resolving and participants confirmation
• Auditors skills management
• Audit preparation based on past audits and inspections
• Audit conducting with FDA & CE Checklists assistance
• Site responses collection, responsibility acceptance, and CAPAs
• Generate and signed report (Electronic signature CFR 21 part 11)
• Observations and CAPA management
• Powerful and flexible permissions
• Full audit trail and history
• Full search, statistic and trends
• Management dashboards and graphs (management, Auditors, Site QA head)
• Users and groups management