Qualification & Validation

Qualification & Validation

Your strategist for practical applications!  The relevant authorities believe that qualification and validation of your processes ensure the performance and safety of your medical devices! Chemgineering as your partner and strategist for mastering these challenges practically and sustainably over the long term. The life cycle of your medical devices forms the basis for Chemgineering’s recommendations and solutions.

 

Frequently requested support services in Qualification & Validation include:

  •  Qualification – working with appropriate technologies and methods
  •  CSV – computer system validation
  •  Electronic records & signatures – confidence with Part 11
  •  Test method validation – trusting the result
  •  Process validation – confident control of production

 

 What can Chemgineering do for you? We will be pleased to advise you on your questions and challenges!

Your contact person Frank Studt

Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com