Process Control and 21 CFR Part 11
T800 Visual Supervisor
The Visual Supervisor is a cost effective "Mini DCS",combining HMI (Human Machine Interface), Process Control and Data acquisition in one device, which can be used as a stand alone "unit solution" or as a building block within a larger system. The Visual Supervisor, together with the Eurotherm 2500 remote IO system offers a highly flexible and high integrity control system. It offers advance regulatory control, sequential control, batch and recipe capabilities together with "built-in 21 CFR Part 11" features required for pharmaceutical and healthcare applications.
The T800 Visual Supervisor is a multi-function unit providing all the features that are required to control and monitor units (e.g. reactor, freeze dryer, Water purification systems, fermenters, autoclaves, sterilisers, etc). It combines Eurotherm's well-established expertise in Industrial control, data management and process automation into a single cost effective unit. The Visual Supervisor's custom displays provide easy and quick access to all the information required by the operator to monitor and control the operation of the plant effectively.
The Auditor feature on the Visual Supervisor has been specifically designed to meet the requirement of the FDA's 21 CFR Part 11. Data security is paramount for FDA approved processes- Visual Supervisor ensures that the data is not lost or tampered with. The Auditor features provide comprehensive data security and tractability.
"Tamper proof" Log files can be configured to include logged process data, report data, audit trails (logins, alarms, events, operator notes, recipe actions, batch actions, parameter changes, etc) with electronic signatures. Data is held in both human readable and electronic form. Electronic data can be viewed, analysed and printed off-line using the secure Review package.
With the Auditor feature, Electronic signature is configurable for all actions which maybe performed form the Visual Supervisor display including the customised displays and the standard features such as batch, recipe changes, access control changes, etc.
Additionally on multiple Visual Supervisor node systems, the central control of all security functionality can be achieved with the Security Manager utility. Security Manager is a stand-alone software package with a tamper proof audit trail which is used to globally define the security configuration for a system. It provides updates to user accounts, logins etc., and the ability to distribute the security setup to all subscribing nodes.
The Visual Supervisor features include:
- Batch Manager to ISA-S88 with "tamper proof" batch log
- Advance recipe handling
- Accurate continuous and sequential control
- Powerful setpoint programmer
- Comprehensive data logger with "tamper proof" log files
- Integrated IP65 operator display with Touch screen
- Open I/O network - simultaneous support for Profibus DP master, Modbus master and slave
- User configurable display
- Printer support - Print alarm, events, and reports
- Local disk drive
- Barcode reader/scanner support
- Support for external keyboard
- Audit Trail, Historical Alarms, and Alarm Summary page
Documents:
Tight integration with popular SCADA systems is also possible, providing high level visualization of the data and full connectivity to high-level computer systems.
EurothermSuite Operations Server & Viewer
The EurothermSuites' family of Supervisory systems including Operations Viewer and Serverwith built in 21 CFR Part 11 provide a central repository for logging data, audit trails and electronics signatures in "tamperproof" files.
EurothermSuite's Operations Viewer & Server is a PC Based system designed to provide overall management and control of a complete process. It includes Invensys Wonderware's world leading software InTouch software and is designed to meet the diverse needs of operations, maintenance and plant management.
The simple to use display structure provides data to users in a fast and meaningful way. Standard features include client/server architecture with master/backup servers, pre-defined display structure, trending, sophisticated alarm functionality, single global database, and time synchronisation.
The Operation Server & Viewer has been specifically designed to meet the requirement of the FDA's 21 CFR Part 11. Data security is paramount for FDA approved processes- Operations Server & Viewer ensures that the data is not lost or tampered with.
The Auditor features provide comprehensive data security and tractability. Audit log files can be configured to include logins, alarms, events, operator notes, recipe actions, batch actions and parameter changes and each entry can have an Electronic signature. Data is held in both Human Readable and Electronic form. Electronic data can be viewed, analysed and printed off-line using the secure Review package.
21CFR Part 11 related security issues in this product are handled by the Security Manager utility, a stand-alone software package with a tamper proof audit trail. Security Manager is used to globally define the security configuration for a system. It provides updates to user accounts, logins etc., and the ability to distribute the security setup to all nodes.
The Operation Server & Viewer features include:
- Pre-engineered "works out of the box" application based on Wonderware InTouch
- Full system wide availability of all control data
- Client/server architecture with master/backup servers
- Sophisticated alam functionality including alarm history MS SQLServer
- On-line Tag Browsing to all LIN objects throughout control network
- Supports LIN, Modbus and OPC server connectivity with in-built communications error detection
- Open I/O and system network using serial, Ethernet and Arcnet
- Integrateded Development Environment including auto-configuration techniques
- Support for multiple languages
- Project database provides common system data repository
- Easy to configure and deploy multiple computer nodes
Documents:
- EurothermSuite Operations Viewer & Server and the 21 CFR Part 11 ERES
- EurothermSuite Information Manager Product Brochure
Security Manager
The routine ageing of passwords would create a significant management task for a cluster of 21 CFR Part 11 validated devices. Each operator having to update his/her password on each device can create the probability of passwords being locked out and poor practice being developed. Eurotherm has developed a stand alone software package, Security Manager, which provides a central point for administrating users and password control removing this barrier completely.
Security Manager is designed to satisfy the requirement of 21 CFR Part 11, and it is intended to globally define the security configuration for a system. Where a system includes remote devices including:
- Operations Viewer (PC workstation)
- T800 Visual Supervisor
- Series 5000 Recorder
Once users have updated their password on the "security Manager" the security information is deployed to the nodes subscribed to the "security Manager". All security changes are treated as events and will be stored in "tamper proof" audit trail file. There are no limits to the number of current and retired users.
This package creates a tamperproof, audit trail file of all password maintenance.
The primary data configured by Security Manager are:
- Users - Individual user accounts
- User groups - Collections of users who have the same access rights to the system
- Security items - Objects protected by security. Typically these are instruments, PCs, or programs that require users to logon before they can use them
- Security zones - Collections of security items, for which user groups have the same access rights
