Documentation from the Information Point of View

Information can be derived from data. The nature of the information obtained depends on the type of data being used. If it is meta-data (data about data), it can provide information that is necessary for the traceability of all processes. Is it result-related data, like raw data, for example, primary electronic raw data such as chromatography data files on the hard disk of the measurement computer, it can be associated with sample preparation data to calculate quantitative data, which are used in subsequent steps of the information generation process. 

The following considerations apply to the verification documents at the lowest level of the document hierarchy shown in Section 8.2. The main objective of the verification documentation is that for all GxP-relevant processes traceable information is generated, accessible for the legally prescribed retention period. The purpose of the following meta-data model is to enable the complete traceability of the information and data, using the meta-data. From this information, no results can be derived, but they are an indispensable part of the raw data. 

In batch-oriented quality management systems, such as good manufacturing practice (GMP), the batch number of an active substance or a product is the main index variable, where the entire information about sourcing of materials, manufacturing, analysis (control), packaging, and distribution is attached. 

In study-based quality management systems, such as good laboratory practice (GLP) and good clinical practice (GCP), the study number is considered as the main index variable and any other information along the meta-data model can be derived from it. With the help of the meta-data model (see Box Meta-Data Model), it can be checked easily if the information of the documented GxP-relevant process is complete. 

Sample/materialAiatch Method/process Instrument/system/equipment Filed path/location of data 

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