ABSTRACT
Document hierarchies In Chapter 1, we identified the need for SOPs as part of quality control systems required by ICH E6 GCP. SOPs, however, do not stand alone; even at the smallest of companies, activities described in SOPs require the support provided by associated forms, templates, and more detailed work instructions. SOPs and the other supporting document types are often illustrated in the documentation describing a company’s quality system (the quality manual) by a pyramid showing the document hierarchy. This chapter introduces a novel version of the document hierarchy diagram, which will be referenced throughout this book. The simple hierarchy shown in Figure 2.1 and the more complex hierarchy in Figure 2.2 are tailored specifically to clinical development activities and show the types of documents linked closely to SOPs. The document hierarchy uses the concepts of controlled documents and managed documents, which we will explore first.
