Page Comparison

The PHUSE project team will extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied.

The TransCelerate MSA framework published in 2021 has completed its mission to develop a framework for building an open-source software computing environment for clinical analysis and reporting. Since TransCelerate does not sponsor building of solutions, demonstrating the use and benefit of the MSA framework with specific tools and concrete implementation steps could not be realised. A PHUSE handover of the project grants the opportunity to look at real-world solutions and implementations.