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Project Scope

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.


Problem Statement

Historically, when using proprietary statistical programming languages, communicating the version metadata of the statistical procedures/functions used to generate analysis has been done within the SAP with a general statement as to the software and version used. With the growing popularity of open-source statistical programming languages, it is no longer necessary to provide metadata on each package as a general statement.



Project Leads

Email

Joel Laxamana

laxamana.joel@gene.com

Lovemore Gakava

lvgk@novonordisk.com

Alex Pearce, PHUSE Project Assistant

alexandra@phuse.global


Status
colourBlue
titleCurrent Status
Q3 2024

  • Member recruitment 



Objectives & DeliverablesTimelines
White PaperQ1 2025