PLANNING, DEVELOPMENT AND IMPLEMENTATION OF A DIGITAL ARCHIVE

Autori polaze od činjenice da bi proces uspostave digitalnog arhiva trebao biti planski i sistematično proveden. U radu uvodno obrazlažu potrebu za takvim pristupom. Potom opisuju Agenciju za lijekove i medicinske proizvode kao specifičnog stvaratelja gradiva, jer će ju kasnije koristiti kao primjer konkretne realizacije teorijskih uvjeta za uspostavu digitalnoga arhiva od povjerenja koji može dugoročno očuvati autentične elektroničke zapise. Pri tome opisuju trenutne postupke s dokumentacijom o lijeku te postojeće i nadolazeće standarde njezinoga elektroničkoga formata zapisa. Nakon utvrđivanja postojećeg stanja, autori analiziraju uvjete koje digitalni arhiv mora zadovoljiti kako bi bila uspostavljena i očuvana autentičnost elektroničkih zapisâ i digitalnog arhiva. U sklopu toga apliciraju apstraktni OAIS referentni model na konkretni planirani digitalni arhiv Agencije. Autori nastavljaju s pojašnjavanjem projektnoga pristupa izradi digitalnog arhiva kroz IPA projekt. Završno je prikazana konkretna realizacija apstraktnih zahtjeva analiziranih normi za uspostavu digitalnog arhiva od povjerenja kroz IPA projekt Agencije "Priprema za eCTD i uvođenje digitalnog arhivskog informacijskog sustava".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\u27s 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\u27s IPA project "Preparations for eCTD Implementation of Digital Archival Information System"