Concept Papers

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...

1 Introduction Over the past decade, the life sciences industry has seen cloud-based services and solutions evolve from a misunderstood technology...

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

Data integrity is a global expectation as evidenced by the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance, published in January...