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2022 ISPE Europe Annual Conference

EU22CEAPR1/SES311 - Data-driven QMS (document-free)


Apr 26, 2022 5:10pm ‐ Apr 26, 2022 6:00pm


Description

The Quality Management Future is digital, user-friendly, precise and intuitively easy-to-understand. It is accessible from everywhere and provides the “right information at the right time at the right place” in a customized attractive format, as text, voice, or picture/video. The digital transformation is progressing the in the LifeScience Industry. The value of data as an asset to competitive imperative has been understood. Interoperability of data is one of the key requirements of digitalization likewise for a digital Quality management system. What does this mean for a Quality management if quality requirements will be managed as defined modular information unit, preferably as single source of truth, seamlessly integrated into digital operations? This presentation will illuminate the various aspects of Quality 4.0 for operators, quality leaders, regulators, and how to go practically go through such a major transformation, and how could the application of digital technologies themselves like Natural Language Processing will facilitate the extract and structuring of data.

Speaker(s):

  • Heike Roeder, Director, Lead Digital Quality, Risk Advisory Life Science, Deloitte

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