The 18th Official GAMP® 5 Conference was a true highlight for us at Digital Life Sciences GmbH. Together with experts from authorities, industry, and technology, we conducted an in-depth analysis of the current developments surrounding Annex 11, AI in the GxP environment, cybersecurity, SMARTfacturing, as well as many other future topics.
The keynote “From MANUfacturing to SMARTfacturing – Now or never” impressively demonstrated how strongly digitalisation and automation are transforming the life sciences sector. In the subsequent exchange with representatives from authorities and industry, the targets and intentions of the new Annex-11/22 Drafts were intensively examined – a topic that particularly concerns us as a software manufacturer in the regulated environment. Furthermore, the discussion rounds provided valuable insights.
The second day of the conference was characterised by profound insights into the usage of AI in the GAMP environment, modular systems based on MTP, and the requirements from NIS-2 and Annex 11 in the sector of cybersecurity. Practical discussions on audit trail reviews and the conflicting compliance interests between users and suppliers rounded off the program.
The concluding panel discussion “GAMP 5 meets Annex 11” made it clear that our industry is at an important turning point and emphasised the increasing significance of collaboration.
In addition to the professional input, networking – particularly at the social event in the BASF Society House – was a true highlight. The personal exchange once again confirmed the high value of a vibrant community in a highly regulated environment.
Our conclusion:
We were able to gain numerous inspirations and concrete impulses for the continuous development of our software solutions, particularly regarding quality, security, and regulatory compliance. Our thanks go to all speakers, organisers, and participants for this successful event.
We are already looking forward to the next conference next year.
