SAS^® Health and Life Sciences Solutions that enable FDA Title 21 CFR part 11 compliance, include:

• SAS^® Drug Development versions 4.5 and lower
• SAS^® Life Science Analytics Framework 4.6 and higher

For additional information:

• "The Quality Imperative SAS Institute's Commitment to Quality", Appendix 1: Complying with Title 21 CFR Part 11
• "Part 11, Electronic Records; Electronic Signatures — Scope and Application", Food and Drug Administration

Operating System and Release Information

Product Family	Product	System	Product Release		SAS Release
			Reported	Fixed*	Reported	Fixed*
SAS System	SAS Drug Development	Linux for x64	4.5		9.4 TS1M1
SAS System	SAS Life Science Analytics Framework	Linux for x64	4.6		9.4 TS1M3

* For software releases that are not yet generally available, the Fixed Release is the software release in which the problem is planned to be fixed.

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FDA Part 11 compliance electronic records audit trails version

Type:	Usage Note
Priority:

Date Modified:	2016-05-19 15:31:15
Date Created:	2002-02-12 16:10:40