Forming an Understanding of GCP and a Validation Strategy at Nycomed Imaging

Abstract

During the last decade, Nycomed Imaging has grown from a very small, mostly nationally based Norwegian pharmaceutical company to a somewhat larger international one. This growth, both in terms of size and professionalism, has led to very rapid changes in the way it manages clinical data. The validation of computer systems has been one of Nycomed's major focuses during the last couple of years. This has resulted in a corporate validation handbook which expresses the company philosophy on the topic. On the basis of this handbook, approximately 20 validation standard operating procedures (SOPs) have been written, describing the procedures related to acquiring, testing, and validating computer systems. These procedures answer the basic questions of when, how, and who. The contents of the “Validation Handbook” and validation SOPs are described in this paper. Nycomed has also just begun gaining experience in actually performing a few validations. The experiences from validating the randomization and labeling sy...