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Desktop Systems

	Microsoft^® Access^® Databases
	Microsoft^® Excel^® Spreadsheets

File Based Systems

Database Management Systems

EDMS

eInfotree Excel Plug-In Solution

Background

Microsoft Excel spreadsheets are ubiquitous in the industry, with uses ranging from storing laboratory data, process data, systems inventory, calculations, instrument parameters and maintenance logs.

Selected 21 CFR Part 11 Issues for MS Excel Applications

21 CFR Part 11 Compliance for MS Excel Spreadsheets

	Security: Files are stored on local hard drives or network servers, and maybe easily accessible to unauthorized individuals.
	Lack of Audit Trail: There is no audit trail of changes made to the file, even when made by authorized personnel.
	Lack of Password Management: Passwords, if they exist, may not comply with password management requirements of 21 CFR Part 11.
	Lack of Password Aging: Passwords, if they exist, may not comply with password aging requirements of 21 CFR Part 11.

The eInfotree Plug-In Solution

The eInfotree Plug-In solution provides 21 CFR Part 11 compliance for MS Excel spreadsheets, with:

	Security: Access to the file is only available to authorized personnel. Users must login to have access rights to the file.
	Audit Trail: All changes made to the file are logged in an audit trail.
	Electronic Signatures: Electronic signatures can be enabled or disabled based on system configuration.
	Password Management: Fully compliant with Password Management requirements of 21 CFR Part 11.
	Password Aging: Fully compliant with Password Aging requirements of 21 CFR Part 11.
	Session Timeouts: User sessions will automatically time-out after a configurable period of inactivity.