Generica QMS is used for managing Quality Audit processes, including Internal sites and External suppliers Audits, Auditors Management, Suppliers Management and Pharmaceuticals Co-Vigilance Audit. The Quality Audit Management module can be implemented as an independent solution or as an additional and integrated quality audits module.

Quality Audit Management in Your Natural Working Environment

Generica QMS Audit Management solution comprehensively addresses quality audit challenges, including audit planning and conflict resolution, participant confirmation, audit preparation, audit conducting, observations and CAPA remediation, auditors and skills management, resources management and reports management. Quality trends can be tracked and managed using the solution’s dashboards.

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 Quality Audit System

List of Modules

• Internal Sites Audit
• External Suppliers Audit
• Auditors Management
• Suppliers Management
• Pharmaceuticals Co-Vigilance Audit

Features

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

• Inspections and Inspections observations management
• New inspections observations rollout and sharing
• Review, check, fixed and confirm capabilities
• Inspectors management
• Audit preparation based on past inspections
• Full search, statistic and trends
• Management dashboards & graphs (Management, Auditors, Site QA head)
• Periodic reports
• Powerful and flexible permissions