Cloud ALM – News for the GxP Environment

Cloud ALM for the Regulated Environment

A roadmap outlining the planned implementation of requirements for the pharmaceutical and medical industry was presented at the recent SAP ALM Summit 2023. XEPTUM played an important role in formulating these requirements.

The SAP ALM Summit EMEA conference was held in Mannheim, Germany on October 10 - 13, 2023. Over the past year, SAP has worked hard to implement new features and improve the usability of Cloud ALM. Additional key milestones were reached and presented during the Summit, especially in the areas of Solution Documentation (document management) and Test Management (test plan creation).

The concepts and features that will enable Cloud ALM to meet the regulatory requirements for the pharmaceutical and medical industry were also presented at the Summit. This is encouraging for two reasons:

At the beginning of the year, SAP hosted a workshop to discuss precisely what industry customers require from the future ALM solution. Representatives from XEPTUM participated in this workshop and used their expertise to make significant contributions to future features and concepts. Specifically, the requirements around digital signatures and their integration into ALM processes were discussed. However, according to the latest information available, SAP will not provide a digital signature feature. XEPTUM will therefore provide solutions for this functional gap in Cloud ALM.

Secondly, SAP demonstrated a strong customer focus and a high degree of transparency. Not only did SAP outline its future plans for Cloud ALM, but they also invited the community of partners and end customers to help shape this path. It was therefore all the more satisfying to see that SAP had given consideration to many of the points and features discussed at the workshop and was able to present a promising roadmap for customers in the pharmaceutical and medical industry at the Summit.

We, at XEPTUM, continue to closely follow the development of Cloud ALM, especially for end customers in the GxP environment, and we look forward to keeping you up to date on Cloud ALM.