FDA BA/BE data integrity and its 2 linked instruments

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First column: FDA BA/BE data integrity. The others are every document linked to it.
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Details: Guide Definitions: every term and label explained

	FDA BA/BE data integrity	ICH E6(R3) GCP	FDA electronic systems Q&A
Authority	FDA	ICH	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Draft	Final	Final
Last verified	Not yet	Not yet	Not yet
Summary	Draft FDA guidance for applicants and testing sites on achieving and maintaining data integrity in the clinical and bioanalytical parts of bioavailability and bioequivalence studies.	Revised ICH guideline on good clinical practice. FDA says it adds flexible, risk-based approaches and embraces innovations in trial design, conduct and technology.	FDA recommendations for sponsors, clinical investigators, review boards and contract research organisations on using electronic systems, records and signatures in clinical investigations, and when FDA treats them as equivalent to paper records and handwritten signatures.
Lifecycle	3 Apr 2024 Draft guidance issued	8 Sep 2025 Published by FDA as final guidance	1 Oct 2024 Final guidance issued (October 2024)
Source	Official text Source: FDA. Public domain.	Official text Source: ICH.	Official text Source: FDA. Public domain.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.