21 CFR Part 11 System

	StatLIA Validation Package Excerpts PDF File
	StatLIA Overview
	Data Reduction
	Statistical QC
	Interfacing
	Data Tracking
	Parallelism
	Multiplex


21 CFR Part 11 System Requirements		StatLIA 3.2
Audit Trails
	Generate Secure Records of Transactions	YES
	Record Date, Time, Identity, and Transaction	YES
	Prevent Original Data from Being Overwritten	YES
	Prevent Signature of Record from Being Altered	YES
	Time-stamp of Record Must Reflect Local Time	YES
	Store Initial Raw Data from Instrument	YES
	Ability to Record Notes about Transaction (Required for GLP Laboratories)	YES

Security
	User Name and Password	YES
	Prevention of Duplicate Passwords	YES
	Historical Record of Controlled Transactions	YES
	Prevention of Falsifying Electronic Signatures	YES
	Authority Checks to Verify Permitted Access	YES
	Automatic Notification of Inappropriate Access	YES
	Automatic Time-Out After Inactivity	YES
	Password Aging	YES

Electronic Record Systems
	Advanced Report Generating Capability	YES
	Display Data Electronically and by Hard Copy	YES

Links from Signatures to Records
	Maintain Signatures as Long as Records	YES

Web Design and Development by Elan Web Services

21 CFR Part 11 System Requirements