Manage audit activities

Innovating, easy to implement and use,  GxpManager Audit application enables to manage, conduct and centralize all audit activities.

GxpManager Audit manages all steps of an audit. Audit data is centralized and capitalized. Corrective and preventive actions follow-up is ensured.

GxpManager Audit is a ready-to-use solution in compliance to ISO 19011 and perfectly adapted to requirements of industries with high quality constrains.

Benefits

• Plan audit activities
  
• Manage standards
  
• Download regulatory standards
• Manage audit checklists
  
• Manage audit evidence
  
• Manage audit findings
  
• Define action plans
  
• Accomplish audit follow-up
  
• Ensure compliance to GxP, SOx, ISO, ICH, GAMP, …
• Reduce audit activities workloads and costs
  
• Capitalize audit data
  
• Coordinate and supervise audit actors
  
• Edit dashboards, indicators and metrics
• Automatically publish audit documents
  

Who should benefit from GxpManager Audit?

To all managers concerned by audit activities:

• Audit Manager
  
• Program Director
  
• Project Manager
  
• Quality Assurance Manager
  
• Regulatory Affairs Manager
  
• Information Systems Manager
  
• Engineering Manager
  
• Manufacturing Manager
• Quality Control Manager
  
• ...

Pilot with GxpManager Audit

GxpManager Audit enables to organize the entire audit planning: goals, audit teams and dates. Auditors' skills management is part of the application. Many dashboards, indicators and charts can be edited automatically.

Examples of ready-to-use audit questionnaires

• Active Pharmaceutical Ingredient (based on ICH Q7)
• Computerized and Automated Systems (based on GAMP 5, ISO 9001)
• Software and application solutions (based on IEEE, GAMP 5, ISO 9001)
• Metrology subcontractors (based on ISO 17025 and ISO 9001)
• Distribution subcontractors (based on GDP and Drug Monitoring)
• Manufacturing subcontractor (based on cGMP)
• Machines and equipment (based on GAMP 5)
• Sterilization subcontractor (based on cGMP, ISO)
• Information system hosting (based on GAMP IT, ISO)

Audit reports generated automatically

GxpManager Audit reduces the time required to editt the audit report. Published using a predefined template, the audit report is generated automatically.

Which audit can be managed by GxpManager Audit?

• Raw materials supplier audit
  
• Information systems supplier audit
• Computerized systems supplier audit
• IT supplier audit (host, data center, archiving, integrator, developer, etc.)
• Subcontractors supplier audit (production, distribution, laboratories, metrology, sterilization, CRO, investigation centers, archiving)
• Internal audit
  
• IS/IT developer / integrator for custom systems departments audit
• Quality departments audit: quality control, quality assurance