Concept Papers

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...

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

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

1 Introduction It is well understood that each clinical trial is conducted and managed as an independent project even if several trials investigate...

1 The Need for Access Point to any country on a map of the world. That’s where you might find a patient in urgent need of a new therapeutic option...

1 Introduction The principles and processes for the validation of computerized systems are well-known and understood within the Good Manufacturing...

1 Introduction This document provides guidance on good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated...

1 Background and Purpose 1.1 Team Composition The authors are members of the ISPE global PAT COP Data Management Task Team. The mission of the Team is...

1 Introduction It is current practice to use booklet labels for labelling of Investigational Medicinal Products (IMPs) to be used in multinational...