Remote Login and Audit Trail Fully Automated to the Field Level
With the functional extension FW4400-081 for the Protos II 4400 multiparameter transmitter, we enable you to implement audit trail requirements in accordance with FDA 21 CFR Part 11, ALCOA++, and EU GMP Annex 11 in a fully automated manner, from the process control system to the field level.
Fully automated remote login with two-factor authentication for access control to the measuring point
Fully automated audit trail logbook for complete recording of all events. The audit trail records are made available for retrieval via various fieldbus systems.
Calibration reports are provided for transfer to the company database.
Communication between Process Control System and Measuring Point
Audit trail records are automatically generated for:
- Login, logout, auto logout
- Changes in device configuration
- Manual or automated calibration via cCare system
- Firmware updates, module installation
- Time synchronization
- Start of cCare system programs, service status, and messages
- Sensor connection with sensor data (Memosens and digital sensors)
- Termination of connection to the sensor
- ...
Remote Login – Two-Factor Authentication
FDA 21 CFR Part 11, ALCOA ++ and EU GMP Annex 11 require all events to be assigned to a person who makes changes, which is why access control at the measuring point is a mandatory requirement.
The central user database in the company's own authentication system is used for login. User IDs, user roles, and user rights are directly specified and managed in the central authentication system.
The administrator can flexibly access rights for each menu. Depending on their rights, users can view or access the calibration, parameter settings, maintenance and diagnostics. Remote login can be implemented as two-factor authentication. Login requires a user ID, password, and comment for access. Optionally and individually, administrators can generate an access key for each user as enhanced access control in order to make access control and security at the measuring point even tighter. The following functions can be used with a few simple fieldbus commands.
Central System |
Protos II Device |
|
Two-factor authentication |
The company's own authentication system is directly used for login by entering the user ID and password, RFID card, etc. |
Authentication on the panel enables access to the selected Protos II in accordance with the respective access rights. Example: Enabling local operation at Protos II for
|
Enhanced security procedure by generating a 4-digit access key that can be displayed on the panel or sent via text message, email or Messenger. |
The access key enables access to the device. This method is beneficial if the login terminal and Protos II are located far apart. |
Auto logout |
A timeout value for automatic logout can be specified for each user if the user is no longer actively working at the device. It is still possible to manually log out from Protos. |
If the user does not log in or execute a security-relevant action on Protos after a specified period of time, the transmitter will automatically log the user out. |
User and rights management |
All users with roles and rights are managed in the company's own authentication system. |
Flexible assignment of user groups and user rights ranging from read only, device configuration changes, measuring point maintenance, and pH sensor calibration to the administrator with full access rights. |
Audit Trail Record
Every event that generates an audit trail record will be made available for retrieval via the fieldbus interface as a separate, line-based entry in Protos II.
Every record is identified by a consecutive sequence number, a date stamp, a TAG, etc. and is provided as plain text (text encoding UTF-8).
Data transmission can be automated via various fieldbus interfaces. This way, an audit trail record is generated in the transmitter directly at the time of the triggering event and made available for retrieval and saving in the database of the process control system. It is no longer necessary to permanently save audit trail records in the transmitter. If fieldbus communication is interrupted, Protos II buffers up to 512 audit trail records for an unlimited period of time until they can be retrieved with the fieldbus again. The language of each audit trail record corresponds to the language that was set for the user interface in the transmitter.
Regulatory Requirements
In regulated areas, rigorous specifications apply for electronic systems:
- FDA 21 CFR Part 11 (USA)
- EU GMP Annex 11 (Europe)
- ALCOA++ Principles of Data Integrity
In addition to the database, data security, protection against manipulation and unauthorized access are the top priorities:
Data integrity: Complete, seamless, immutable, and traceable recording
Electronic signature & records: Secure access control and user identification with user ID, time stamp, and reason
Audit trail logbook: Electronic documentation of all messages, access attempts and changes to the measuring system as audit trail records, protected against manipulation
The audit trail solution for Protos II completely fulfills these requirements and helps operating companies to comply with rigorous specifications (compliance).
ALCOA++
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete
- Consistent
- Enduring
- Available
Calibration Record – Detailed Recording and Direct Transmission to the Process Control System
Each time the sensor is calibrated and adjusted, a complete calibration record in plain text is made available via various fieldbus interfaces for retrieval and transfer to the databases.
The calibration record contains more than 50 pieces of data, including the:
- Time stamp
- User in accordance with login
- Calibration mode
- Sensor data such as serial number, type, etc. for Memosens and digital ISM sensors
- Zero point and slope
- Limit values
- Delta (deviation)
Additionally, after each calibration an audit trail record with the following information will be made available for retrieval from the database:
- Calibration with time stamp
- Calibration success status
- Type of calibration, e.g., 2-point calibration
Automated time synchronization via PLC in Protos II ensures that the correct time stamp is always present in both the audit trail record and the calibration record.
Control of the cCare System from the Process Control system via Fieldbus
In the cCare system, the Protos II transmitter is also used as an operating unit for setting intervals and cleaning and calibration procedures for fully automated maintenance of the pH sensors.
The various programs of the cCare system can be controlled and monitored from the control system. This includes starting the cleaning and the 2-point calibration of the sensor, as well as visualizing all of the executed program steps and generated messages directly in the process control system. This makes it possible to take full advantage of the benefits of a fully automated measuring point for 24/7 operation.
Integration into Process Control Systems
Protos II transmitters make the data available for a complete system audit trail via fieldbus. In order to retrieve, visualize, and save the data sets and for access regulation, the customer must program the PLC.
Knick provides prepared basic function modules for relevant functionalities. This simplifies the development of the automation program and the integration of devices. However, the complete PLC programming and individual adjustments are the responsibility of the operating company.
Module for remote login function: Login requests with name, access authorization, and login reason are sent from the PLC to the transmitter via fieldbus.
Module for audit trail function: The PLC retrieves the audit trail data from the transmitter and makes it available for further archiving.
Module for calibration record: The PLC reads out the calibration data at the transmitter, where it is prepared for saving.
Minimize your process risks with full automation!
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The Protos II 4400(X) transmitter is a modular multiparameter transmitter whose rugged stainless steel housing with a hygienically optimized surface makes it ideal for applications in hygienically demanding environments. It is certified as a 4-wire system for use in potentially explosive atmospheres.
The modular concept of the Protos multi-parameter transmitter offers maximum flexibility by allowing the integration of three different, freely combinable measurement and communication modules. The usage of this functional extension needs either a ProfiNET or Profibus communication module.
Download our Audit Trail brochure for an overview of the Audit Trail firmware option FW4400-081 for Protos II.