Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiative—which is promoting a risk-based, product quality, and patient-centric approach to computerized systems assurance—as well as the GAMP® reexamination of approaches to IT infrastructure control and compliance.
Feature: Real-world evidence (RWE) is clinical evidence regarding the usage and potential bene ts or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery. RWE helps healthcare companies better understand and establish stronger evidence of products’ performance, clinical value, and cost-effectiveness outside the controlled environment of clinical trials. Outcome-based studies are increasingly depending on RWD and RWE to speed up drug development and approvals, and ultimately reduce development costs.
Feature: In 2021, the ISPE GAMP® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient safety, product quality, and data integrity.
Technical: What if the reliability of a system could be improved by accessing the standard data provided with modern process instrumentation? These data, accessed from existing instrumentation, can be used to analyze the fitness of processes, equipment, and instruments; better understand processes; support discrepancy investigations; and provide a data-driven basis for the timing of maintenance and calibration. This article covers a few particularly illustrative examples in detail.