The Life Cycle Model for Regulated Documents in Practice

In general, specification and verification documents can be distinguished, while in practice mixed forms of both document types exist. Atypical specification document in the laboratory is a test specification, which contains all the requirements for carrying out the analysis starting with the mixing of solutions and reagents to the calculation of the analytical results. As a typical example of a verification document (record), a weighing record can be quoted. A mixed form of specification and verification documents is often found in test protocols that contain both requirements and relevant attestations [11]. 

The document control has to describe all activities of creation, review, approval/authorization, distribution, modification and versioning, withdrawal, and archiving, and make it traceable for all quality review activities. 

In practice, particularly records are subjected to a thorough review by a second person (four-eye principle), which proves the accuracy, completeness, and compliance with internal and external requirements. For electronic data, besides accuracy, integrity, availability, and human readability have to be safeguarded (Table 8.4). 

The Life Cycle Model for Regulated Documents in Practice 

The life cycle model of regulated documents officially starts with the planning of a document and ends with the withdrawal or deletion. Each individual document in the analysis process contributes to the traceability and quality of the result. Therefore, at least the following points need to be defined for each document (see Table 8.5). 

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