ISPE announced the release of its latest Guide, ISPE GAMP® Good Practice Guide: Enabling Innovation–Critical Thinking, Agile, IT Service Management.
The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
This GAMP® Good Practice Guide provides information to support the adoption of current best practice in software engineering, data management, and ‘as a Service’ offerings (XaaS), including encouraging the use of supporting tools and automation, thus facilitating the best use of resources and the application of appropriate, up-to-date, and proportionate approaches.
The application of critical thinking, adoption of incremental and iterative (Agile) software development models and methods, and utilization of modern IT service delivery options enables the life-science industry to provide innovative solutions to support the development and advancement of patient health.
This new GAMP® Good Practice Guide shows how these concepts are interwoven: applying critical thinking when leveraging iterative software development practices and using both concepts to underpin the delivery of IT service through appropriate management of IT Service providers.