Skills and Expertise

Through the interventions of its manager, Quavalex has already fulfilled numerous activities, for example :

• Definition of qualification strategies for a new radiopharmaceutical production factory located in the United-States.
• Qualification of production line for radioactive drug manufacturing (shielded isolator) (including “Factory/Site Acceptance Tests” phases).
• HVAC qualification (Heating, Ventilation and Air Conditioning).
• Controlling system qualification for environmental parameters.

Qualification also implies the writing of all the documents :

• Directly implicated in the V-Model (User Requirement Specifications – Functional and Design Specifications – qualification protocols DQ, IO, OQ and PQ).
• Intervening to support the qualification according to the V-Model (component, functional, and process risk analysis - commissioning protocol, FAT and SAT – traceability matrix – use and maintenance procedure – etc.).

Quavalex is also able to provide « high level » documents such as the « Validation Master Plan ».