At Ramboll we believe that validation should be included in the project from day one. It is essential that an early risk assessment considers which installations and systems that need qualification. The risk assessment needs to be documented to the proper authorities in order to make it clear that you are in control and that the current level of validation is an ongoing consideration.
Ramboll has experience with extensive validation and testing activities, performed for the biggest pharmaceutical companies in the country, meeting Danish, European and US (FDA) requirements.
Ramboll stays at the forefront of the newest standards in specifications of cleanrooms and can perform accurate risk assessments based on the validation level of the facility.
We have extensive experience drawing up the relevant documents such as the validation master plan, DQ, IQ and OQ protocols, as well as the concluding reports.