The International Society for Pharmaceutical Engineering (ISPE) has announced the release of its latest good practice guide, titled: Enabling Innovation – Critical Thinking, Agile, IT Service Management.
Improving patient safety, product quality and providing value to society while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, the ISPE argues, some practitioners may apply rigid approaches that fail to meet the needs of the process, the nature of the system, and create real risk to the product and the patient.
The latest 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, aiming to promote the best use of resources.
“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,” said Guide Co-Lead Chris Clark, Director, TenTenTen Consulting.
“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,” said Guide Co-Lead Heather Watson, Director Computer Systems QA, GlaxoSmithKline.
