Generica QMS is used for managing Global Risk processes. The Corporate Risk Assessment module can be implemented as an independent solution or as an additional and integrated module.

Generica QMS risk assessment solution provides internal sites risks map, ensures the quality team resources are spending at the right place. Generica QMS risk assessment improves quality and reduce company risk by providing sites’ risks picture in different areas, focusing the quality team activity to the most critical place . Generica QMS risk assessment algorithm base on several parameters such as site classification, audit, inspections and more, and it can be customized to the company risk metrology. Corporate risk assessments are performed more efficient and more effective.

Corporate Risk Assessment in Your Natural Working Environment

The product brings Corporate Risk Assessment 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 Corporate Risk Assessment.

Features

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

• Quality Risk Assessment Model/Algorithm using:
  • Sites classification (e.g. Site type, Site Size, Site Location, Product Type, Product Market, etc.)
  • Audit results (e.g. Last Audit, Number of Critical Observations, Number of Repeat Observations, etc.)
  • Inspections results (e.g. Last Inspection Date & Rate, Inspections Gap Analysis & Trends, Number of Inspection Observations)
  • Management Factoring
• Risk Map
• Trends Analysis
• Integration with Audit Planning module
• Management dashboards & graphs (Management, Auditors, Site QA head)
• Periodic reports