dcsimg Qualification and validation - Ramboll Group
      
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Qualification and validation

 
 

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.

 

Learn more

 
Cleanroom Technology
Clean Room Technology
For more than three decades, Ramboll has specialised in cleanroom technology in close cooperation with the pharmaceutical industry.Learn more in the brochure (English version on page two)
Cleanroom Performance Testing
Clean Room Performance Testing
Ramboll is always adopting the latest standards in classification and testing. Learn more about clean room performance testing in our brochure (English version on page two)

Contact

Ole Torp Madsen
Ole Torp Madsen
T+45 5161 6484
Eotm@ramboll.dk
Carsten Rasmussen
Carsten Rasmussen
Senior Chief Consultant
T+45 5161 1359
Ecras@ramboll.dk