ISPE Publishes ISPE GAMP® Good Practice Guide: Enabling Innovation

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The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest Guide, ISPE GAMP® Good Practice Guide: Enabling Innovation–Critical Thinking, Agile, IT Service Management.

“This Guide supports best practices in software engineering, data management, and ‘as a Service’ offerings, including supporting tools and automation, facilitating resources, and the application of up-to-date and proportionate approaches,” said Guide Co-Lead, Sion Wyn, Director Conformity Ltd.

The International Society for Pharmaceutical Engineering (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,” said Guide Co-Lead, Sion Wyn, Director Conformity Ltd.

“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.

Purchase the ISPE GAMP® Good Practice Guide: Enabling Innovation–Critical Thinking, Agile, IT Service Management online, available at ISPE.org/Publications/Guidance-Documents, among ISPE’s other detailed education resources on a variety of industry topics.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000+ Members of ISPE provide solutions to complex pharmaceutical industry challenges through innovation, member and workforce development, technical, regulatory and compliance collaborations in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

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Kristin LeMunyon
ISPE
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