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# ISPE Wants Data Integrity Guidance Clarified
- URL: https://www.fdaweb.com/ispe-wants-data-integrity-guidance-clarified/
- Published: 2016-10-26T12:00:00.000Z
- Updated: 2026-09-14T21:42:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137179

The International Society for Pharmaceutical Engineering says a draft FDA guidance on data integrity and compliance with current good manufacturing practice provides greater clarity on many issues surrounding data integrity, but further clarifications are needed. The group [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-D-1113-0056&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) the guidance needs to capture important risk-based principles and should clarify how metadata related to advanced monitoring is expected to be maintained and archived. It also calls for addition of a glossary including definitions for terms such as raw data, data, and true copies.