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Manual processes still dominate the shop floor, where people on the production line have been left to deal with paper, spreadsheets and other standalone systems to create, maintain, approve and release production records.
Life sciences organizations are increasingly moving away from document-dependent quality management methodologies and toward a more data-centric model.
In 2019, the U.S. Food and Drug Administration (FDA) introduced its Technology Modernization Action Plan (TMAP), a program designed to bring the organization up to speed with the latest technologies in order to expedite breakthrough discoveries with the intent of improving public health.