Computer System Validation (CSV) in the past often has been anticipatedas an obscure IT topic. However, the addendum of ICH E6 stresses not only the need for validation, data integrity, and data privacy, but also indicates that this is not only an IT issue anymore: "The responsibilities of the sponsor, investigator and other parties with respect to the use of the computerized systems should be clear, and the users should be provided with training in the use or the systems."
Additionally, new technologies (e.g. cloud computing in its different forms) and increased outsourcing to Software as a Service vendors prove to be challenging to remain in control of the data.
The 2-day course provides an overview of the regulatory requirements, guidance documents, and best practices regarding computer system validation in a GCP environment. It is designed to assist those working in clinical operations to ensure that their data is secure and can be trusted. The course covers not only the typical CSV processes (including GAMP 5) and the responsibilities of the different stakeholders, but also IT security and some basic European data privacy requirements are in scope.
Lectures provide sound knowledge regarding the validation of all kind of computerized systems and devices while interactive workshops & cases will assist participants to apply this knowledge to the needs of their own organizations. We have added a second day to this program, to include more practical sessions on importance of using Software as a Service, devices, and digital signatures especially with regard to archiving and record retention