06.06.26 -- Focusing On Data Readiness And Infrastructure

Happy Saturday! This week’s editorial focus is on data readiness as an enabler for automation and AI-based technologies.

Discussions around AI and automation have become inseparable from those on data governance and infrastructure, as the latter is foundational for the former. In this guest column, Kivi Bio CEO and founder Todd Kapp provides takeaways from a conference on data readiness, where the structural disconnect between data generation and data usability was highlighted as a core problem in the industry.

For more on AI and what it means for the future of GMP, check out Bioprocess Online’s interview with Brendan Cuddy, the EMA’s lead scientific officer and chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG). It covers Cuddy’s involvement in efforts to expand regulatory reliance, support Annex 1 implementation, strengthen inspector training, and develop the agency’s thinking on AI in GMP environments.

Last but not least, check out this guest column from BioPhorum on how to evolve commissioning, qualification, and validation (CQV) in an increasingly digital manufacturing environment.

Before you go, check out some selected content from our partners below!

Tyler Menichiello                          
Chief Editor, Bioprocess Online

Honeywell Life Sciences replaces paper with digital procedures and eLogbooks to reduce errors, strengthen compliance, and accelerate production.

ValGenesis enables validation teams to shift from manual bottlenecks to AI-driven CQV, accelerating timelines, strengthening compliance, and reducing audit risk.

Veeva can transform stagnant compliance training into engaging, role-based learning that sharpens decision-making and strengthens quality culture—explore how.

Emerson shows how smarter data strategies and connected processes help life sciences teams accelerate innovation, improve flexibility, and confidently deliver treatments faster.

CAI advances commissioning and qualification by adopting iterative, risk‑based practices that enable earlier issue resolution, stronger readiness, and more reliable startups.

Körber Pharma reveals how end-to-end digital twins transform manufacturing with smarter control strategies, faster development, and real-time optimization.

Siemens examines how MTP standardizes module communication, cuts integration complexity, and enables agile, scalable production to accelerate commissioning.