Description

The advantages of this technology are numerous with data being collected and available electronically it can be transmitted to any PC anywhere in the world over a LAN connection. It can also provide users with remote access to the system.  One drawback is that the system and therefore the data could be left vulnerable to attack by unauthorized users.

Security Manager greatly reduces the cost and resource required to implement changes to secure systems by allowing the operation to be carried out from a central or multiple designated PC.

Security Manager is a centralized security system where User Names, Passwords and Access Permissions can be controlled. Designed to assist with Federal Regulation 21 CFR Part 11 for the Pharmaceutical Industry. Security Manager can also be used to aid users in meeting the guidance as detailed in GAMP4 Appendix 03 – Guidelines for Automated System Security.

Audit trail

Security Manager provides a tamper resistant audit trail for the following events.

• User Login/Logout
• Failed Login Attempts
• Saving configuration changes to the
• Security Manager Database
• Deployment of Security Manager
• Database

The Security Manager Audit Trail can be examined using Eurotherm Review Software.

Unique password

In order to ensure that user passwords remain unique throughout the life cycle of the product, retired user IDs are retained.

Electronic signatures

The use of electronic signatures within Security Manager is configurable, if enabled, users are required to enter signing and/or authorization signatures for updating the Security Manager Database. If signatures are required only those users with appropriate access permissions are able to sign and/or authorize.