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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. to Industry 4.0