Generica QMS is used for managing Quality Audit processes designed for planning, execution, reporting and follow up, including corporate Internal Quality Audits (e.g. Internal Manufacture Sites). It can be implemented as an end-to-end audit solution including internal audits and external audits, or only for one audit type and several processes.

Internal Quality Audits in Your Natural Working Environment

The product brings Quality 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 an Internal Audit Management System.

Features

To achieve full coverage of Internal Quality Audits, the following functionality is covered:

• Yearly/Quarterly audit planning
• Plans Conflicts resolving and participants confirmation
• Auditors qualifications management based on auditors’ skill set
• Audit preparation based on past audits and inspections
• Audit conducting with FDA & CE Checklists assistance
• Site responses collection, responsibility acceptance, and CAPAs
• Generate and sign reports (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 & graphs (management, Auditors, Site QA head)
• Risk Assessment
• Users and groups management