Traceability and therefore the documentation of production data is becoming increasingly important in many sectors such as the pharmaceutical industry, the food and beverage industry, and the related mechanical engineering industry.
Therefore, sector-specific and cross-industry standards have been developed for the electronic documentation of production data.
The most important set of regulations is the FDA guideline 21 CFR Part 11 for electronic data records and electronic signatures issued by the FDA, the US Food and Drug Administration. In addition, different EU regulations apply, such as EU 178/2002, depending on the industry.
Requirements for production systems in these industries have been developed on the basis of 21 CFR Part 11 and the corresponding layout to comply with GMP (Good Manufacturing Practice). They are also required for other industries.
The following main requirements are derived from these directives and regulations:
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Creation of an Audit Trail or operating trace in runtime
Based on this document, it is possible to trace the user who carried out the operator action on the machine at what time.
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Important process steps must also be assigned to a clear responsibility, for example, via an electronic signature.
GMP (Good Manufacturing Practice)
If necessary, activate the GMP-compliant configuration in the Runtime settings.
GMP is also displayed in the properties of a tag of a PLC user data type used in an HMI device even if it is not enabled in the specific device but the tag is used in an additional device that uses GMP. The menu command "GMP" is grayed out in this case and cannot be edited.