摘要：The authors start with the assumption that a digital archive implementation procedure should be a planned and systematic process. Firstly, they explain the need for such an approach. Then they describe the Croatian Agency for Medicinal Products and Medical Devices as a specific records creator because they will later use the Agency as an example of the concrete realisation of theoretical requirements for creation of a trusted digital archive capable for the long-term preservation of authentic electronic records. Therefore, present document and records management procedures are explained as well as effective and incoming standards of their (non) electronic formats. After analysis of the present procedures in the Agency, the authors continue to analyse the requirements a digital archive has to fulfill in order to establish and assess the authenticity of electronic records. They apply an abstract OAIS Reference Model to the concrete (planned) Agency's digital archive. The authors continue by explanation of the project approach to planning, development and implementation of a digital archive by using IPA project as an example. Finally, they show the concrete realisation and application of analysed abstract requirements for the creation of a trusted digital archive through Agency's IPA project "Preparations for eCTD Implementation of Digital Archival Information System".
关键词：digital archive; Agency for Medicinal Products and Medical Devices; electronic Common Technical Document (eCTD); Enterprise Content Management System (ECMS); Instrument for Pre-Accession Assistance (IPA); Open Archival Information System (OAIS); Project Cycle Management (PCM); Trustworthy Digital Objects Objects (TDO)
