It is a rare and wonderful legacy to have substantially improved your chosen industry and to have bestowed a name on an initiative that, 30 years later, has become synonymous with best practice. This article celebrates both these pivotal achievements of Anthony (Tony) Trill, who passed in 2024.
This special anniversary article addresses the history and milestones that define the GAMP Community of Practice (CoP). In celebration of the 25th anniversary of the creation of GAMP Americas, we reflect on the vital role GAMP Americas has played in that journey. We commemorate key accomplishments of its members, share recent activities, and look ahead to the future of GAMP Americas.
Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by a team with the necessary process, product, and functional understanding. Conducting risk assessments prematurely may lead to invalid assessment of overall risks. Conducting risk assessments too late will limit the opportunity to address design flaws and effectively test processes and...
In this blog post, Charlie Wakeham, Director of WakeUp to Quality and Chair of the ISPE GAMP® Global Steering Committee, shares a recap of the ISPE Australasia Digital Innovation Conference, which took place 24 – 25 September 2024.
Computer software assurance (CSA) has been discussed widely in industry over the past five years. While the principles are well understood and welcomed, until now some of the practical detail on how exactly to implement CSA into an organization has been missing.
It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best...
