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# Top Five 2024 FDA Data Quality Issues
- URL: https://www.fdaweb.com/top-five-2024-fda-data-quality-issues/
- Published: 2025-02-18T12:00:00.000Z
- Updated: 2026-09-14T14:53:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Biologics, Drugs, Devices, #legacy-id-D5158674

In a guest *Med Device Online* column, ERA Sciences executive director **Eva Kelly** lists and analyzes FDA’s top five citation issues for data quality in 2024\. The [issues](https://www.meddeviceonline.com/doc/these-were-fda-s-top-citation-issues-for-data-quality-in-0001?vm%5FtId=2709264&vm%5FnId=91823&user=af07de6f-3851-4b1a-b184-d350b10f9e44&gdpr=0&vm%5Falias=These%20Were%20FDA%27s%20Top%20Citation%20Issues%20For%20Data%20Quality%20In%202024&utm%5Fsource=mkt%5FMDOL&utm%5Fmedium=email&utm%5Fcampaign=MDOL%5F02-18-2025&utm%5Fterm=af07de6f-3851-4b1a-b184-d350b10f9e44&utm%5Fcontent=These%20Were%20FDA%27s%20Top%20Citation%20Issues%20For%20Data%20Quality%20In%202024&mkt%5Ftok=MDc1LU5WQy0wODYAAAGYuHlOkjO1hUvnW1cjAooAPkWZoGwSFbh1Fk7reWFfgOHHd5uPJbDpRfrX0tGg0vGd6sfsKtklWX8HEYs4-Q78090oSCp9blbFVOas-uYRXOAL0iA) were:

- governance and standard operating procedure weaknesses;
- validation deficiencies;
- system inventory gaps;
- missing records or data missing key ALCOA++ (attributable, legible, contemporaneous, original, and. accurate) attributes; and
- physical and logical security issues.

Kelly says data integrity remains a top priority for life sciences organizations navigating complex regulatory landscapes. She says companies can better address the challenges by:

- enhancing training;
- regularly revising standard operating procedures;
- conducting regular audits and assessments;
- leveraging technology; and
- maintaining a centralized inventory.