Pharmaceutical Technology Europe
Regular update from Washington.
The US Food and Drug Administration (FDA) is proposing that barcodes be used on drug packages, and that new error reporting standards should be introduced as part of the campaign to reduce medication errors.
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A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.