Concept Papers

Introduction Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production...

Abstract Plug & play in general describes a piece of equipment that is ready to use upon connecting to a computer without any configuration, like a...

Abstract Plug & play in general describes a piece of equipment that is ready to use upon connecting to a computer without any configuration, like a...

1 Introduction Aseptic filling has undergone tremendous development in the past decades, from manned cleanrooms to modern isolator systems, which...

1 Introduction Within the pharmaceutical industry one sees a general drive toward utilizing data across all parts of the value chain. This implies...

1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...

1 Introduction Contemporary communications technologies, particularly those relating to the internet, have the potential to revolutionize...

1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. This...

1 Introduction What should be planned for when implementing a new computerized system, such as a clinical trial database? For clinical computerized...

1 Introduction ASTM defines process capability as the natural or inherent behavior of a stable process that is in a state of statistical control...