{"id":12550,"date":"2026-02-03T16:57:15","date_gmt":"2026-02-03T15:57:15","guid":{"rendered":"https:\/\/dhc.ima.vc\/sap-s4hana-transformation-und-validierung-mit-dem-vorgehensmodell-vital\/"},"modified":"2026-05-09T20:20:43","modified_gmt":"2026-05-09T18:20:43","slug":"sap-s4hana-transformation-und-validierung-mit-dem-vorgehensmodell-vital","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/sap-s4hana-transformation-und-validierung-mit-dem-vorgehensmodell-vital\/","title":{"rendered":"Discovery-Phase als Ausgangspunkt f\u00fcr die erfolgreiche SAP S\/4HANA Transformation & Validierung"},"content":{"rendered":"\t\t
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Discovery-Phase als Ausgangspunkt f\u00fcr die erfolgreiche SAP S\/4HANA Transformation & Validierung<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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How a structured discovery phase in regulated environments defines the north star for SAP S\/4HANA transformations, integrates validation from the start, and reduces risks in GxP projects.<\/p><\/div>\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\tChristian Gasper, Practice Manager - SAP Life Sciences, DHC GmbH\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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The Discovery Phase in SAP S\/4HANA Transformation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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\"\"<\/a>How can pharmaceutical and medical technology companies manage the transition to SAP S\/4HANA not only technically sound but also regulatory-safe and economically sensible? This was exactly the topic of our Life Sciences Alliance (LSA) web session “SAP S\/4HANA Transformation and Validation with the VITAL Process Model” on November 27, 2025. In approximately 45 minutes, Christian Gasper, Practice Manager SAP Life Sciences at DHC Dr. Herterich & Consultants GmbH, and Deniz Dinler, Senior Consultant Transformation Architecture at All for One Group, showed why the transformation is far more than an IT upgrade and how the LSA process model “VITAL” brings together business departments, IT, and quality management on a common path. <\/strong><\/p>\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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Why Now? Regulation, End of Maintenance and Growing Digitalization Pressure<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The SAP ERP maintenance end is approaching: For many SAP ERP 6.0 systems, the standard maintenance periods end at the end of 2025 or 2027 respectively; an optional Extended Maintenance is only possible until 2030. After that, only a limited “Customer Specific Maintenance” with significantly reduced functionality and increased risk remains, for example regarding legal changes and security updates.<\/p>

For regulated companies in life sciences, with GxP-critical processes, audits, and inspections, this is not a realistic option. The switch to S\/4HANA is therefore no longer a question of “if” but of “when and how.”<\/p>

At the same time, regulatory requirements are tightening. Companies must permanently meet and demonstrate compliance with requirements such as EU GMP, Annex 11, 21 CFR Part 11, ISO 13485, and the GAMP 5 guidelines. In addition, there are trends such as end-to-end digital value creation, cloud technologies, cybersecurity requirements, increasing automation, and the use of AI-supported analytics.<\/p>

Classic ECC landscapes are reaching their technical and organizational limits here. In the web session, it became clear: SAP S\/4HANA is the future digital core, but only one building block of a more comprehensive transformation and digitalization strategy.<\/p>\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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SAP S\/4HANA Transformation as a Journey Toward the \u201cNorth Star\u201d<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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At the center of the session was the question of how companies define their individual “north star” for the SAP S\/4HANA transformation. This refers to a multi-year target state that equally considers people, processes, and technology. At the people level, it concerns competencies, role profiles, and change management; at the process level, end-to-end digitalization and data quality; and at the technology level, topics such as cloud, automation, analytics, and AI.<\/p>

The speakers made clear that this north star must not be static. Regulatory guardrails, technological possibilities, and business models continue to evolve, so the target state must be regularly reviewed and adjusted. VITAL, the process model of the Life Sciences Alliance<\/strong><\/a>, ensures that these perspectives are integrated from the beginning rather than being defined “retroactively” into an ongoing S\/4 project.<\/p>\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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Discovery als Startpunkt: von Technical bis Business Transformation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The starting point is a structured discovery phase, in which the type of transformation that makes sense is clarified. The speakers distinguished three variants: a more technically oriented transformation, where processes are largely retained and the system is primarily technically lifted to S\/4HANA; a process-oriented transformation that puts improvements, harmonization, and standardization of workflows at the forefront; and a business transformation that goes beyond processes and also fundamentally questions the operating model, new business models, and end-to-end process chains.<\/p>

In this phase, the company’s strategy and vision are reflected against the existing process and system landscape. Process maps and sub-processes are analyzed, the IT architecture is evaluated technically and from a regulatory perspective, system scans and readiness checks are applied, and the maturity of the organization and documentation regarding IT compliance and validation is assessed.<\/p>

The result is a defined north star, a multi-year transformation roadmap, rough project plans, and a solid estimate of risks and budgets.<\/p>\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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Greenfield, Brownfield, Bluefield\u2122 & Co: Technologieentscheidungen im regulierten Umfeld<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Another key focus was on the different transformation approaches. The classic new implementation (“Greenfield”) enables a complete system rebuild with consistent process harmonization, sensible for heterogeneous landscapes, heavily grown custom developments, or fundamental business model changes. The system conversion (“Brownfield”) technically lifts an existing ECC system to S\/4HANA, fundamentally preserving processes and data, but requiring the implementation of all mandatory technical tasks such as Business Partner, new asset accounting, S\/4HANA simplifications, and potentially a new general ledger.<\/p>

In between, selective approaches (“Bluefield\u2122” or Selective Data Transition) are becoming established: Here, a parallel project environment is typically set up into which selected configurations and data are transferred. This allows historical data to be migrated in a controlled manner while processes are simultaneously modernized in a targeted way.<\/p>

In the session, it became clear: For regulated life sciences companies, it is not only the technical feasibility but above all the validatability of the chosen strategy that is decisive.<\/p>

In addition, the question of the operating model arises. Public cloud variants are often only suitable to a limited extent for life sciences practice due to regulatory requirements. Private cloud models such as SAP S\/4HANA Cloud Private Edition or classic on-premises operating models often emerge as the preferred target architecture, which can be aligned with a GAMP 5-compliant validation approach and proper infrastructure qualification.<\/p>\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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The LSA Process Model VITAL: Transformation and Validation in One<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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A central conclusion of the web session: In regulated environments, SAP implementation and validation cannot be meaningfully separated. This is exactly where the LSA process model “VITAL” comes in. It fully integrates computer system validation (CSV) into the transformation process and is aligned with GAMP 5, relevant GMP regulations, and life sciences best practices.<\/p>

Instead of running two separate project tracks for “IT” and “validation,” validation activities are planned and implemented along the project phases: from validation plan and risk analysis through process and functional specifications to risk-based test concepts ranging from informal tests through functional and integration tests to formal IQ\/OQ\/PQ and end-to-end tests. The validation of data migration, infrastructure qualification, especially in cloud scenarios, and the establishment of operational processes, SOPs, IT service management structures, and training concepts are also integral parts of the model.<\/p>

This integrated approach reduces duplicate work and media breaks, creates transparency for auditors and inspectors, and ensures that the system can be operated in a validated state not only at go-live but throughout the entire lifecycle.<\/p>\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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What Participants Are Particularly Concerned About: Validation, Change, and Data<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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A live survey during the web session clearly showed where the greatest challenges lie from the participants’ perspective. More than half named documentation, validation, and compliance as the most important area. Change management and training as well as data migration followed. Cloud topics were addressed comparatively rarely, an indication that many companies are currently struggling primarily with “classical” GxP questions, resource bottlenecks, and the complexity of their own process and system landscape.<\/p>

This is exactly where the Life Sciences Alliance with its solution building blocks comes in: industry-specific process maps and industry templates, a validation-ready S\/4HANA target architecture, training packages and courses, a digital validation platform for electronic documentation, and a practice-proven IT compliance framework with role, SOP, and operational concepts.<\/p>\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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Conclusion: S\/4HANA Transformation as a Strategic GxP Initiative \u2013 Not Just an IT Project<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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The web session made unmistakably clear: For companies in pharma, medical technology, and biotech, the S\/4HANA transformation is not a “normal” ERP migration. It is a business-critical, regulated digitalization journey where strategy, processes, technology, and compliance must be synchronized. Those who set the course early, orient themselves to a clear north star, and use an integrated approach like VITAL reduce project risks, accelerate implementation, and ensure that the new S\/4HANA landscape confidently withstands the next audit.<\/p>

\u2192 More about the VITAL\u00ae process model for integrated SAP S\/4HANA transformation & validation <\/strong><\/p>\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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Next Step: Your Expert Consultation with the Life Sciences Alliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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If you would like to better assess your own starting position, whether you are at the beginning of your considerations or already discussing concrete S\/4HANA plans, we recommend a personal expert consultation with us as part of the Life Sciences Alliance. In this setting, we jointly examine your status quo in IT, processes, and validation, outline possible transformation paths, and assess how the VITAL process model can be applied to your organization.<\/p>\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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Successful SAP S\/4HANA Transformation and Validation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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How can we support you with our life sciences expertise and the integrated process model VITAL\u00ae in your SAP S\/4HANA transformation?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

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FAQs<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Frequently Asked Questions About SAP S\/4HANA Transformation with VITAL\u00ae<\/h2>\t\t\t\t<\/div>\n\t\t
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Why is a structured Discovery Phase so important in regulated Industries? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Because the discovery phase clarifies whether you need a technical, process-oriented, or genuine business transformation, and how GxP and CSV requirements can be integrated from the start. This creates a realistic “north star” with a roadmap, risks, and budgets, rather than having to make costly corrections later during the ongoing project.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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What does the \u201cNorth Star\u201d mean in the context of SAP S\/4HANA Transformation? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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The north star describes your multi-year target state regarding people, processes, and technology. It consolidates topics such as roles, end-to-end processes, data quality, cloud strategy, automation, and analytics and serves as a guiding orientation that is regularly adapted to new regulatory requirements and technological developments.<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t
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How does a Technical Transformation differ from a Business Transformation? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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A technical transformation (similar to brownfield) primarily lifts the existing system to S\/4HANA. A process-oriented transformation focuses on harmonization and standardization. A business transformation goes further and also questions the operating model, end-to-end process chains, and business models, including the implications for GxP, CSV, and governance.<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t
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Which Transformation Approaches (Greenfield, Brownfield, Bluefield\u2122) are suitable for regulated Industries? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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In principle, all approaches are possible, and the decisive factor is their validatability. Greenfield is suitable for highly grown, heterogeneous landscapes and requires a new, GAMP 5-compliant validation concept. Brownfield preserves more continuity but demands a thorough assessment of existing risks and legacy issues. Selective approaches (Bluefield\u2122) combine controlled data migration with targeted process modernization; here, a clear data and testing strategy is key.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Which Operating Models are realistic for GxP-regulated S\/4HANA Landscapes? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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In practice, many pharmaceutical and medical technology companies choose SAP S\/4HANA Cloud, Private Edition, or on-premise models because they combine well with GAMP 5, infrastructure qualification, and established CSV methods. Public Cloud is used more selectively and in areas where GxP requirements are lower.<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t
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What is the VITAL\u00ae Methodology of the Life Sciences Alliance? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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VITAL\u00ae is an integrated process model that interlinks SAP S\/4HANA transformation and computer system validation (CSV) from the very beginning. It is aligned with GAMP 5 and relevant GMP regulations and describes how validation plans, risk analyses, specifications, test concepts, data migration, infrastructure qualification, and operational processes are structured progressively along project phases.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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How does VITAL\u00ae help reduce GxP risks and validation effort? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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By making validation not a separate track but part of the transformation logic: risks are identified early, test scope is determined on a risk basis, duplicate work and media breaks are avoided, and documentation is created in parallel with the project phases. This facilitates audits and ensures that the system remains in a state of validation throughout its entire lifecycle.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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What typical pain points does the Life Sciences Alliance address in S\/4HANA projects? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Above all documentation and validation, change management and training, as well as data migration. In addition, the LSA provides industry-specific process maps, validation-ready S\/4HANA target architectures, training, digital validation platforms, and a proven IT compliance framework.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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When is an expert consultation on the S\/4HANA transformation with VITAL worthwhile? <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/rect><\/path><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<\/rect><\/rect><\/path><\/stop><\/stop><\/linearGradient><\/stop><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Whenever you want to gain a clearer view of your starting point – whether you are still in an early orientation phase or already discussing concrete S\/4HANA scenarios. In an expert consultation we can clarify which transformation approach fits your regulatory requirements, what your North Star may look like, and how VITAL can be applied specifically to your organization.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\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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More Articles from the Blog<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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