When you have a new facility built you will need to demonstrate and record that it has been designed, installed and performs, meeting all applicable requirements, both your own and those of your regulatory body.
Technickon ltd will write, execute and manage using our own qualification system, documenting the entire process to give you peace of mind that all of these requirements have been fulfilled.
Competence in writing and executing a qualification protocal requires fully understanding the applicable regulations and cleanroom systems. Technickon have experience of the regulations and expertise in all areas of facility design and the engineer that executes the qualification process will give careful attention to ensuring that all aspects of the protocol are adequately developed and executed.
Our qualification system has been designed in house and sucessfully used as a model by many client QA departments operating in the pharmaceutical industry – we receive a very positive response from Clients using our system.
Throughout the entire process we involve key client personnel ensuring transparency and only move on to the next stage when all personnel are fully signed on to the completion of the previous stage.
We also provide our qualification service in isolation and can undertake this service for facilities built by others – offering a third party checking service which is unbiased.
Call one of our engineers today to discuss your qualification requirements or to find out more about the service we can provide.