Documentation from the Organizational Point of View

On the middle level are the concrete specification documents for the operational level, which describe certain work processes and are also considered to be controlled documents, that is, they are subject to change control. Examples of documents on this level are, for example, standard operating procedures (SOPs), test instructions, manufacturing instructions, packaging instructions, specifications, calibration instructions, or maintenance instructions. 

On the lowest level are the records that are partially filled by hand. This includes all documents from verification of the sampling, the printouts of the processed raw data up to the printouts of the final report of an analysis, a method development and validation, or for example a certificate of analysis (CoA). 

For the list of the process steps in which documents are created, it pays to consider the entire information chain and list it for instance in tabular form (see Table 8.1). 

With this model, the complete information chain of a laboratory is made visible starting from the suppliers to the customers and valuable insights are provided for handling of documents that contain the essential data and information. For the proper treatment of the documents during creation, modification, distribution, and archiving, it is necessary to determine in which data formats they are available. Hence, it can be decided in what manner it should be possible to keep the data accessible, recoverable, and legible during the retention period. 

Case 2 Box Practical Tips for Identifying the Process Steps and the  

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