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.
The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE released the second edition of ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice. It addresses managing complexities associated with decentralized clinical trials, the benefits and challenges of using open-source software, and...
It is an exciting time in life sciences. Many companies have focused initial artificial intelligence/machine learning (AI/ML) adoption efforts on developing and implementing ML trained algorithms, which necessitate following a controlled approach such as the GAMP® 5 ML Sub-System methodology shown below. This blog highlights key artifacts and considerations when implementing AI/ML for GxP use...
Stakeholders across industries are becoming accustomed to using information technology (IT) systems, applications, and business solutions that feature artificial intelligence (AI) and machine learning (ML). Even though some of these uses show phenomenal performance, thorough risk management is required to ensure quality and regulatory compliance are met within the life sciences industry. By...
ChatGPT and other large language models are positioned to change the world. They can also shift acceptance and prevalence of machine learning solutions in regulated industries in general. However, their arrival requires reconsiderations on risks, quality assurance, and validation from a GxP perspective.
We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all...
