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,...
Product
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Special Reports
The smart factory, the factory of the future, the Industrial Internet of Things (IIoT), and Industry 4.0. These are buzzwords that populate a new manufacturing world triggered by digitalization. “Pharma 4.0” is a holistic operating model for...
Technical
The amount of data collected in a typical pharmaceutical manufacturing operation is staggering, yet research shows that much of this information is rarely used for anything more than compliance. New technologies such as big data, artificial intelligence, machine learning, and deep learning permit...
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 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...