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# Draft Drug Data Integrity Guidance Out
- URL: https://www.fdaweb.com/draft-drug-data-integrity-guidance-out/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135367

> FDA has issued a draft guidance, *Data Integrity and Compliance with CGMP*, to clarify the role of data integrity in current good manufacturing practice for drugs. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf?ref=fdaweb.com) says that the agency expects that data will be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. “Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models,” it says. The guidance is organized in a question-and-answer format.