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,...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
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,...
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...
Special Reports
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...