Standard-Compliant Monitoring of Measurement Data
Securely capture production parameters electronically that require verification
In the production of food or pharmaceutical products, there are high requirements regarding production, storage, and transportation conditions in order to exclude any hazard for the consumer. This is the reason why critical process parameters such as temperature and moisture are carefully monitored and documented. Nowadays, electronic records are preferred. With its guideline 21 CFR Part 11, the U.S. Food and Drug Administration (FDA) sets a recognized standard that determines the conditions under which electronic records and electronic signatures are recognized by the FDA as valid proof.
Testo AG in Lenzkirch is a leading manufacturer of measuring and monitoring systems. With the measuring system Saveris™ Testo offers a product family for the distributed, wireless monitoring and recording of temperature and moisture values. Testo has also developed an FDAcompliantSaveris variant that corresponds to the particularly strict requirements of Part 11. Since the regulations of 21 CFR Part 11 allow some room for interpretation, the manufacturers and users of Part 11-regulated systems are worried whether their technical and organizational implementation will really be accepted by the FDA. Testo therefore decided to collaborate with Fraunhofer IESE in order to have the standard compliance of its Saveris series independently validated. With Fraunhofer IESE, they found a natural competence partner for such a check, since most of the requirements relate to properties of software and software-related processes.
In this collaboration project, the task of Fraunhofer IESE mainly consisted of eliciting and running through all Use Cases that are Part11-relevant when using the measuring system and to check whether all the requirements of the CFR guideline are fulfilled completely in terms of such performance features as authentication, authorization, user guidance, data integrity, dataauthenticity, or data availability. The top principle of 21 CFR Part 11 is that only authorized employees may obtain access to the measurement data, and that each interference with the data or with the measuring system must be traceable at all times and must be allocable unambiguously to a specific user. Furthermore, it must be ensured that the recorded data can be reproduced true to the original at all times during the entire burden of proof period and can be presented to the FDA for checking in a suitable format.
For the conformance checks, a reference configuration was set up at the institute and subjected to systematic tests. During the course of the evaluation, Fraunhofer IESE was able to identify various critical usage steps whose technical implementation was modified systematically in order to ensure unambiguous standard compliance even under adverse conditions and at acceptable costs in the best possible way. Concurrently, instructions were designed for the system user to help him/her operate the system in compliance with the guidelines.
The result was a checking report created by Fraunhofer that provides comments on all requirements of 21 CFR Part 11, point for point, and demonstrates how the Saveris system implements the respective requirement and which concomitant measures (so-called proceduralcontrols) the system user should take to fulfill his burden of proof towards the FDA. With its documented standard compliance, the measurement system Saveris™ of Testo AG opens up promising market opportunities in FDA-regulated usage environments.