{"id":16130,"date":"2026-05-05T10:27:49","date_gmt":"2026-05-05T08:27:49","guid":{"rendered":"https:\/\/dhc.ima.vc\/?p=16130"},"modified":"2026-05-09T20:20:27","modified_gmt":"2026-05-09T18:20:27","slug":"sap-innovation-meets-gxp-compliance","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/sap-innovation-meets-gxp-compliance\/","title":{"rendered":"SAP Innovation Meets GxP Compliance"},"content":{"rendered":"\t\t
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SAP Innovation Meets GxP Compliance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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How must validation approaches evolve in light of current SAP innovations? These challenges were the focus of Stefan Staub\u2019s presentation at the SAP Executive Exchange Forum for Life Sciences 2026 in Zurich.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\tStefan Staub, Partner & Principal Consultant, DHC AG (CH)\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\t\t\tCloud computing \u2014 especially the shift toward public cloud \/ SaaS solutions<\/strong> \u2014 is forcing regulated companies to adapt to shorter release cycles. The number one trend topic, Artificial Intelligence (AI)<\/strong>, will significantly transform processes in the life sciences industry over the coming years through innovative applications. SAP is playing a leading role in this development, continuously making new technological capabilities available through its products.\n\nWhile the regulatory expectation of ensuring product quality, patient safety, and data integrity<\/strong> remains unchanged, the requirements for validation approaches are evolving rapidly. The presentation demonstrated how companies can successfully address these new challenges through risk-based supplier assessment and selection<\/strong> supported by audits and the GxP Cloud Control Matrix<\/strong>, as well as through continuous and automated validation<\/strong> enabled by an End-to-End Digital Validation Platform<\/strong>.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\u201cExciting Times\u201d \u2013 But with New Compliance Challenges<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tOne of the key principles in the cloud context can be summarized in a single sentence:\n\nMany responsibilities are no longer under the direct control of the regulated company \u2014 but accountability remains entirely with the company<\/strong>.\n\nThis tension between shared responsibility<\/strong> and one-sided accountability<\/strong> (\u201cshared responsibility but one-sided accountability\u201d) explains why supplier selection and supplier qualification<\/strong> in cloud environments are not simply a \u201cnice to have,\u201d but an absolute necessity. No company wants to discover only after signing a contract that a provider is unable to deliver GxP capabilities or qualification support \u2014 and then face audits or inspections without adequate evidence. Regulatory requirements therefore mandate that this selection and assessment process be carried out before the collaboration begins.\n\nThe following illustration further explains this across the cloud service models (IaaS\/PaaS\/SaaS<\/strong>): providers are responsible for areas such as secure operations, change management, and data integrity<\/strong>, while the regulated organization must demonstrate that the provider fulfills the required standards (qualification<\/strong>) and must validate that applications are \u201cfit for intended use.\u201d<\/strong>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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From \u201cLinear & Document-Centric\u201d to \u201cContinuous, Risk-Based & Automated\u201d<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Many validation approaches originate from a time when software was comparatively static. As a result, computer system validation (CSV) approaches became highly documentation-driven, in some cases even paper-based, and followed the linear structure of the traditional waterfall model. To some extent, this is still true today \u2014 but these approaches are increasingly perceived as too slow, bureaucratic, and costly.<\/p>

The key takeaway: modern IT systems behave more like a \u201cliving organism\u201d that is continuously evolving. Cloud services \u2014 especially SaaS applications \u2014 together with rapid release cycles, are accelerating the pace of change. Emerging AI applications will further increase these demands.<\/p>

As a consequence, validation must evolve toward continuous validation. Managing this pace manually \u2014 particularly regarding change impact assessments and the required testing activities \u2014 is no longer feasible. Test automation is becoming a necessity, and in the future, AI-based approaches may also support validation activities.<\/p>

In SAP landscapes shaped by cloud services, frequent releases, and new AI applications, future validation approaches and validation tools must therefore provide the following capabilities:<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section>