Information Systems

Technical
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...
InTouch
ISPE's revised IT Infrastructure Control and Compliance Guide provides comprehensive guidance on regulatory expectations for both traditional and cloud-based IT platforms. Have we done enough?
Technical
Recent cyberattacks like WannaCry and Petya have affected GxP computerized systems, prompting questions on how to address risk from cyberspace using traditional computerized systems validation according to GAMP ® 5. This article explores life cycle management of GxP computerized systems and...
Features
The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
Training
The cloud is the future and the future is now. But is the cloud a safe place for pharmaceutical companies to operate? Or is it best to continue hosting and operating software technology solutions on an organization own,...
Training
The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This ' digital asset ' reflects the value of data that mirrors the physical assets. The...
Training
The GDPR (General Data Protection Regulation) is slated to go into effect May 25 of 2018 in the EU. There is no roll-in period as this has been in discussion since 2012. This new regulation will replace the existing EU...
Training
This global SIG coordinates GAMP concepts in promoting the understanding of validation and compliance aspects within R&D, and of clinical computerized systems, with a focus on ensuring data integrity and patient safety....