Monitoring project management
Because each project is unique, the IVTracer monitoring solution can be customized to meet the real needs of industrial pharmaceuticals manufacturers.
In addition to project-specific development, NetCeler also provides engineering, installation, qualification and maintenance services.
This support guarantees the product’s commissioning, optimisation of its use, updating and durability.
Our quality of service is our brand image!
EMS Software Deployment
To support you in the deployment of IVTracer installations, NetCeler offers you the following services :
Field expertise
- Audit of existing installations
- Technical implementation study
- Cartography assistance
Deployment of measures
- Integration of existing equipment
- Deployment of new analogue and digital sensors
Complete project management
- Control of the technical installation
- Regular reporting
- Overall qualification of the system in compliance with the standards in force (FAT/SAT/QI/QO/QP)
Documentation
&
Qualification
A turnkey project, from the URS to the as built documents...
IVTracer was created according to the specifications 21 cfr Part 11. The solution is accompanied by complete documentation in compliance with GMP requirements.
The validation of the system follows the GAMP 5 approach (Good Automated Manufacturing Practice), it takes place in 3 phases:
Phase 1:
Study of needs and technical specification
- URS
- Needs traceability matrix
- Functional analysis (HDS/SDS)
- The list of points
Phase 2:
Preparation of project documentation and materials
- The realization of the plan funds
- The Excel configuration file
- Drafting and approval of SAT (or FAT) documents: protocols and test sheets.
Phase 3:
Realization of commissioning and qualifications
- SAT completion reports
- Intervention reports
- Training materials
Support
&
Maintenance
A service dedicated to listening to you...
IVTracer is based on a robust and redundant architecture at different levels, which gives you peace of mind in maintaining and supporting a critical system.
Interventions take into account the buffering of the different elements of the system. The infrastructure is self-monitoring, allows for preventive maintenance and warns the people concerned in the event of a fault.
Installation support
- Ticket portal web
- Commitments to quality
- Maintenance in operational conditions of deployed systems
- System updates and evolutions