Generica QMS is used for managing Global Quality Audit processes, including suppliers and quality agreements management. It can be implemented as an end-to-end solution for all of the company quality audits or as a standalone solution.
Manufacturers in the Life Science industry are responsible for conducting audits and approving suppliers. Managing global supplier audits avoids duplication regarding suppliers that supply multiple sites; improves process quality; and saves time and effort for the site quality teams. Generica QMS’ supplier and quality agreements management addresses challenges ranging from potential supplier inspection, to the quality approval process, agreements management all the way to external supplier audit planning and execution.
Generica QMS supplier management enables different sites tomanage and control individual suppliers but maintain a global perspective.

Suppliers and Quality Agreements Management in Your Natural Working Environment

The product brings Suppliers and Quality Agreements 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 suppliers and Quality Agreements Management system.

Features

To achieve full coverage of suppliers management, 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