Who should benefit from GxpManager VMP ?

To all managers concerned by policies, organization and execution of all validation work:

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

A powerful and innovating validation tool

The GxpManager VMP solution enables to perform a complete inventory and manage validation and revalidation activities of a  manufacturing site, quality control, servers, facilities, storehouse, equipment, machines, computerized systems, utilities, software, automated systems, process, products, suppliers, projects ...

Validation data management

Planning and follow-up of validation activities

Change control

Validation Master Plan publishing

A global view of your site

With its linking functions, GxpManager VMP enables you to have a global view of your site, facilities, warehouses, equipment, systems, automated systems, process, products, resources, ..

Plan your validation activities

GxpManager VMP enables you to plan all validation activities for resources management, URS definition, schedules,...

Identify the resources

GxpManager VMP enables to identity your site's resources and the people in charge by system or product. You can also assign validation activities to resources for evaluating and planning workloads.

Optimize your workload

With GxpManager VMP, you can optimize your validation plan according to feasibility and priority criteria. You can analyse your validation projects by type of equipment, process, facility, change control or level...

GxpManager VMP enables to adjust your validation program according to changes in projects.

Interface with Microsoft Project©

GxpManager VMP can be interfaced with Microsoft Project© to benefit from a complementary follow-up of activities and resources.

Benefits

• Oversee validation
• Integrate an ICHQ9 risk management policy
  
• Ensure compliance to GxP, SOx, ISO, ICH, GAMP, …
• Reduce validation charges and costs
  
• Respect validation programs and deadlines
  
• Capitalize on validation activities
  
• Coordinate and combine all validation teams
  
• Create dashboards, indicators and metrics
  

Which validations can be managed by GxpManager VMP ?

• Manufacturing processes
  
• Analytical methods and Laboratory equipment
  
• Equipment, Utilities and Facilities
  
• Computerized and automated systems
  
• Cleaning, decontamination and sterility
  
• Facilities classification (ISO classes, Bio-confinement, GxP classes, …)
• Raw material, suppliers and subcontractors
  
• Internal staff and subcontractors
  
• New buildings and new activities
  
• Periodic validation and revalidation
  

Create dashboards

With its powerful analysis functions you can create the dashboards you need to supervise your validation activities. Ensure that the mislestones, targets and workloads are being respected.

Moreover, GxpManager VMP is an open system enabling you to export all your data towards other software such as MS Excel©, Crystal Reports©, ...

Publish in one click your Validation Master Plan

Starting from the data integrated in GxpManager VMP, you can publish in one click your validation master plan in Word or pdf format.

You can very easily customize the content of your document. Nevertheless the standard application is delivered with templates:

• Validation policies
• Validation activities organization
• Statement of installations, systems, equipment and process to validate
• Planning and scheduling of validations
• Change control and revalidation
• Coordinate and combine all Validation actors
• Edit dashboards, indicators and metrics