Agile leadership in GMP-compliant in-house software development
Misukka, Milana (2024)
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-202404237419
https://urn.fi/URN:NBN:fi:amk-202404237419
Tiivistelmä
This action research, commissioned by Bayer Oy, delves into the role of the product owner in an in-house software development project, ensuring Good Manufacturing Practice (GMP) compliance and implementation of Agile project management principles. The research was carried out from the product owner’s point of view. The primary objective was to clarify the key responsibilities and tasks of a product owner working in Agile software development project while ensuring GMP compliance and the delivery of high-quality software.
This research is based on a literature review and discussions with the stakeholders at Bayer. The aim was to adapt methods from theoretical sources of Agile software development processes to the requirements of the pharmaceutical software project. These methodologies were then applied in practice to improve the ongoing software development project.
The concrete aim of this thesis was to engage in the ongoing software development project to build a Minimum Viable Product (MVP) with Bayer’s Manufacturing Science and Technology (MSAT) department. During the project, the product owner ensured that the customer needs aligned with GMP requirements and project’s objectives. In addition, the product owner was involved in the implementation process of Agile principles, while carrying out other tasks related to the product owner’s role in Agile projects.
This research is based on a literature review and discussions with the stakeholders at Bayer. The aim was to adapt methods from theoretical sources of Agile software development processes to the requirements of the pharmaceutical software project. These methodologies were then applied in practice to improve the ongoing software development project.
The concrete aim of this thesis was to engage in the ongoing software development project to build a Minimum Viable Product (MVP) with Bayer’s Manufacturing Science and Technology (MSAT) department. During the project, the product owner ensured that the customer needs aligned with GMP requirements and project’s objectives. In addition, the product owner was involved in the implementation process of Agile principles, while carrying out other tasks related to the product owner’s role in Agile projects.