Fulfill audit trail requirements via fieldbus - Fully automated down to the field level

Strict requirements apply to applications in the pharmaceutical industry. FDA 21 CFR Part 11, for example, requires that all relevant records be documented in a tamper-proof manner. In the case of a process-related measuring point, this so-called audit trail includes configuration changes, calibrations, and login or logout activities. The new front firmware FW 1.4.0 for the Protos II transmitter from Knick integrates full audit trail functionality via a TAN option – making it the first process analysis device to meet audit trail requirements directly through a fieldbus interface. Audit trail records and complete calibration logs are made available to the process control system for retrieval via PROFINET or PROFIBUS. No additional software or external storage media are required.

Database, data security, and protection against unauthorized access

All relevant events – such as faults, alarms, configuration changes, and sensor adjustments – are stored in the audit trail. In addition, login data are recorded. Access to the transmitter can be managed by the higher-level process control system through the Remote Login function, with optional two-factor authentication. Each access is documented with the person, access rights, time stamp, and optional reason for access. The roles defined in the user management of the control system with the various access rights then also apply to the measuring point. This ensures that only authorized personnel have access to the Protos II settings. The complete calibration logs are also made available to the control system via fieldbus.

Function blocks for automation

The Protos II transmitter provides all audit trail data directly on the device, enabling the process control system to retrieve them regularly via fieldbus. To simplify integration of these new functions into the control architecture, Knick offers preconfigured function blocks for selected process control system providers. With the extended capabilities of Protos II, it is easy to implement applications that comply with FDA 21 CFR Part 11 and meet EU GMP Annex 11 or ALCOA++ requirements. In pharmaceutical production, these typically include biotechnology systems and medical device manufacturing lines. Secure, centralized access control to the measuring point via the customer’s authentication system is also relevant for safety-critical processes – for example, in food production or in the chemical industry.

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