In this project with Testo AG, a standard-compliant measurement data processing system was created to ensure electronic recording of production parameters requiring validation.
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In the production of food or pharmaceutical products, there are high requirements regarding production, storage, and transport 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 directive 21 CFR Part 11, the U.S. Food and Drug Administration (FDA) has set a recognized standard that determines the conditions under which electronic records and electronic signatures are accepted 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 FDA-compliant Saveris 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.
The top principle of 21 CFR Part 11 is that only authorized employees may obtain access to the measurement data, and that any 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 compliance 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 users to help them operate the system in compliance with the guidelines.
Fraunhofer Institute for Experimental Software Engineering IESE