In the pharmaceutical industry, traceability is at the heart of business operations. Every batch, every deviation, and every system change is thoroughly documented. With cloud solutions, however, this logic often stops at the contractual boundary when data is processed in jurisdictions that do not completely exclude third-party access. STACKIT solves this dilemma: We provide infrastructure, a contract, and a data center all within the same legal jurisdiction where your regulatory responsibility lies. Verified documentation simplifies your supplier evaluation, while qualified partners ensure smooth operations.
Research, modeling, and study data are your most valuable assets. At the same time, global cloud infrastructures create compliance risks due to potential uncontrolled data outflows or extraterritorial access rights (e.g., the U.S. CLOUD Act).
The personal liability risk for executive management is increasing. In the future, proof of operational reliability and physical resilience must be provided seamlessly across the entire supply chain.
Implementation starting in March 2027 and secondary use beginning in 2029 require well-founded architectural decisions today regarding where and how health data will be securely processed in Europe.
QA departments require robust, verifiable documentation. General security statements are not sufficient for a successful audit; the scope must be defined with crystal clarity.
Protect GxP-relevant core systems such as MES, LIMS, and QMS through automated backup and recovery paths with a traceable audit trail. STACKIT provides the verifiable evidence base for recoverability, while you remain responsible for validation.
Manage incident, change, and deviation processes in compliance with audit requirements via ServiceNow on STACKIT. Crisis communication via WIRE and fallback workstations from openDesk ensure uninterrupted operations. This way, you guarantee business continuity and a rapid recovery even in the event of serious IT outages.
Seamlessly connect distributed research sites and external partners, such as contract research organizations (CROs), via Zscaler on STACKIT. Strict zero-trust security standards protect confidential development data under European data sovereignty.
Use RISE with SAP on STACKIT as a certified platform to securely operate your ERP systems for supply chain, serialization, and manufacturing integration. This allows you to combine the familiar process capabilities of leading enterprise software with the strict compliance requirements of the pharmaceutical industry.
We are responsible for areas such as finance, budgets, resources, portfolio management, as well as controlling and procurement, to ensure you receive the best possible performance.
“In regulated environments, success is not determined by a cloud’s sheer range of features, but by its ability to withstand audits. True data sovereignty for the pharmaceutical industry means that infrastructure providers, contractual partners, and your own regulatory responsibilities all fall within the same legal jurisdiction.”
Holger Kottmann
Senior Sales Manager
Chemicals, Pharmaceuticals & Construction
*As a European hyperscaler recognized by SAP as a suitable infrastructure platform for RISE with SAP, we operate our infrastructure exclusively in European data centers without being subject to the U.S. CLOUD Act. Certifications in accordance with the international ISO 27001 standard—which serves as the fundamental security framework—as well as the BSI C5 Type 2 certification built upon it and GDPR compliance form the verifiable foundation for data management that meets European legal requirements.
