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The ISPE SIG Pharma 4.0 worked since 2017 on concepts around the Digital Transformation process, the implementation methodologies & roadmap, and a Pharma 4.0 Operating Model for pharma organizations. The Pharma 4.0 Baseline Guide will summarize and describe the structured approach for a Digital Transformational Process, including practical Use Cases. The presentation will summarize the key concepts, challenges, current status and learnings from the creation of the Pharma 4.0 Baseline Guide.