ABSTRACT
The importance of the qualification process of technical systems in the pharmaceutical industry has been steadily increasing over the last 10 years. It has been driven primarily by the requirements of regulatory bodies and not by the need to save money in this part of the industry. If the industry made use of the full scope of the GMP requirements, the qualification process would be more efficient and the cost of qualification would drop. On the other hand, pharmaceutical companies want to protect themselves from a less than perfect result during a regulatory inspection and therefore demand 120% effort from their suppliers and service companies. New methods and tools must be implemented to reach the goal of qualifying a technical system while minimizing effort.
