Description
The advantages of this method are numerous, as the collected data is available electronically and can therefore be transmitted via a LAN connection to any PC anywhere in the world. It also allows users to access the system from a remote location. A disadvantage is that the system and therefore the data can be exposed to attack by unauthorized users.
The Security Manager reduces the costs and resources for changes to security mechanisms by allowing the necessary steps to be carried out centrally or from multiple assigned PCs.
The Security Manager is a central security system that monitors user accounts, passwords and access rights. During its development, the focus was on fulfilling the FDA CFR 21 Part 11 regulations. The Security Manager can therefore help the user comply with GAMP Appendix 03 (Guidelines for automated security systems).
Audit trail
The Security Manager provides a tamper-proof audit trail for the following processes:
- User accesses
- Failed login attempts
- Configuration changes in the Security Manager database
- Deployment of the Security Manager database
The Security Manager audit trail can be reviewed using Eurotherm Review Software.
password protection
To ensure an individual, secret user password during the product life cycle, user accounts can only be assigned once and cannot be deleted.
Electronic signatures
The use of the electronic signature within the Security Manager is configurable. If enabled, users are required to sign for access and/or authorize database changes. If signatures are required, only users with appropriate access rights are authorized to sign and/or authorize.
CHARACTERISTICS:
- Forgery-proof audit trail
- password protection
- Electronic signatures
- Designed for secure data capture and storage
- Meets the requirements of FDA CFR 21 Part 11
- Data traffic via LAN connection
- Remote system access
