Insitec S Compliance with FDA 21 CFR part 11

Version 5.4 of the Insitec S software introduces several new features which provide users in the pharmaceutical industry with the ability to achieve compliance with 21 CFR 11 – the FDA's document outlining the requirements for electronic data storage and tracking.

Software Security System
A security system similar to that used in WinNT is now available within the Insitec S software, requiring users to login prior to making measurements. This includes:

	Fully independent operation from the standard Windows NT™ security system, allowing multiple users to use the Insitec S system without the need to log in and out of Windows NT™. Log in and log out can also be achieved without closing the Insitec S software.
	Fully configurable users and groups, allowing the measurement and data analysis permissions to be easily assigned for each user.
	Password aging is available, forcing users to change passwords after a pre-defined period of time. Password histories can also be stored preventing users from using the same password when a change is requested.
	Automatic account lockout following the entry of a pre-defined number of incorrect passwords for a given user.
	A continuous use check is available, allowing automatic log out following user inactivity.
	Accounts can be disabled but not deleted should users leave the company or change roles.

Automatic Back-up Creation.
Key processes such as data deletion and modification are still available when the 21 CFR part 11 software options are enabled, although access to these operations can be controlled using the security system. The user is required to provide a reason for the action when these processes are carried out and an automatic backup of the measurement data is made. This ensures that the results recorded prior to any changes or deletions can be reviewed.

Creation of Audit Trails.
All key measurement and data analysis activities are logged to an audit trail file. This lists the event that has occurred along with the username of the user involved. For key events such as data modification and deletions the user is prompted for a reason for the action which also appears within the audit trail. The current user can also add additional comments to the audit trail in order to flag key events. Audit trails can be created daily, weekly or monthly to meet the requirements of the customer's operating policies.

Electronic Signatures.
Electronic signatures are supported by direct printing to Adobe Acrobat PDF files.