Insights

Perspectives from
the field.

Not polished brochures — but analyses from active projects, regulatory assessments, and thought pieces from life sciences consulting practice.

KIArchitekturGxP

Integrate, Don't Consolidate: AI Makes Best of Breed Affordable

How AI makes interfaces fast, affordable and verifiable and loosens vendor lock-in in the life sciences. In a GxP environment, validation evidence tips the balance, not development time.

Read article →
KIOrchestrierungAnnex 22

SAP invests in n8n — what it means for regulated processes in pharma

Annex 22, in draft since July 2025, is the first GMP framework dedicated to AI in pharmaceutical production. SAP's strategic stake in n8n marks an architectural decision with direct consequences for regulatory practice.

May 18, 2026

7 min read

→
KIStrategieGxP

AI in a GxP environment: build the process house first, then the algorithm

AI transformations in pharma rarely fail because of technology — they fail because of insufficient organizational maturity. Fragmented processes and unclear accountability turn AI into a liability.

April 30, 2026

4 min read

→
OrchestrierungComplianceChange Management

GxP compliance under pressure: why orchestration and AI are the answer to the complexity trap

Fragmented documentation, disconnected tools, and manual analysis processes strain business, IT, and QA simultaneously. The solution is an intelligent integration layer — not yet another standalone system.

April 24, 2026

5 min read

→
CSVSAPValidierung

CSV 2.0: Computer system validation for SAP with SAP Solution Manager and Link.it!

Despite highly automated business processes, system changes in validated SAP environments take weeks. An architectural approach combining SAP Solution Manager, Link.it!, and Tricentis Tosca changes that fundamentally.

February 26, 2021

4 min read

→