Data Stewardship - Its Criticality

A data steward in a pharmaceutical, biotech, medical device, or an R&D clinical company is responsible for the day-to-day management, quality, and lifecycle of data assets within their specific domain. The primary goal of data stewardship relative to 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) and ALCOA++ is to operationalize data governance policies into practical, compliant workflows that guarantee data trustworthiness, patient safety, and product quality. Copyright notice: This copyrighted document may be customized for the purchaser’s needs. Redistribution or resale of the original document is prohibited without permission.