Our team of expert consultants will partner with your organization to provide complete end-to-end Serialization (Track & Trace) support that you need to achieve cost-effective compliance.
We bring world class expertise and support developed from 10+ years of support dedicated to the Life Sciences industry.
Our expert technical consultants and project managers will support your organization with the implementation and qualification of the VIMACHEM SSM Level 3 system as well as with the implementation of the Tracelink Life Sciences Cloud (Levels 4 and 5) , offering an integrated solutions for serialization Levels 3 to 5 that allows reduced implementation time and (pragmatic) end-to-end validation.
During installation and validation execution Vimachem will:
- Install the Vimachem Level 3 Serialization Site Management (SSM) system to two servers (production and test) and perform the installation qualification (IQ).
- Integrate the VIM level 3 site management system to the Tracelink Life Sciences cloud and the line level equipment and perform the installation qualification (IQ).
- Support if requested, with production qualification (PQ).
Vimachem throughout the project lifecycle will provide project management services for:
- Project coordination and communication with global stakeholders.
- Technical requirements and specifications definition.
- URS analysis.
- Scheduling of time and resources, monitoring and change management, continuous monitoring of project milestones.
After the successful qualification of the level 3 site management system, Vimachem will train the resources in the successful operation of the Level 3 site management.