Best Archival Practice in the Regulation of Medicines : Work on the Guidelines for Agencies for Medicinal Products

This paper announces the beginning of the work on the standardization of filing of electronic medicinal dossiers in agencies for medicinal products. Medicinal products electronic dossiers have to be preserved for the long-term because of the requirements for protection of patients’ safety and standardization of archiving procedures

Planning and Designing of Digital Archival Information Systems

Digital archival information systems can be planned and designed by following the most prominent records management methodologies like ISO 15489, related standards and DIRKS, or by following project management approach. Project management approach means planning and designing of digital archival information system as a cost and time-bound project and performing monitoring and evaluation activities in these perimeters. This approach can be done by following different project management methodologies like PRINCE2 or Project Cycle Management. The aim of this article is to explain these available options, to compare them and to make recommendations based on assessment of capabilities of an organisation in which the potential digital archival information system is to be planned and designed. Project cycle management is suitable methodology for organisations in which digital archive developers do not have sufficient administrative capabilities or enough staff with technical know-how to develop digital archive without outsourced technical assistance, but are allowed to apply for European financial aid, such as IPA or other funds in the future

Systems for Managing Digital Documentation – New Opportunities Aad New Challenges for the Creators and Archives

Stvaratelji gradiva u Hrvatskoj sve više počinju raditi s izvorno digitalnom i digitaliziranom dokumentacijom te prelaze s datotečnih sustava na dijeljenim mapama (engl. file system) na sustave za upravljanje digitalnom dokumentacijom. Prelazak na takve sustave nije lagan proces zbog potrebe integracije s postojećim aplikacijama i mnogim drugim rješenjima koja omogućuju rad s dokumentacijom. Novo okruženje donosi prednosti i izazove za stvaratelje i nadležne arhive. Ovim se radom elaboriraju prednosti koje stvaratelj može postići kvalitetnom implementacijom sustava, ali i ističu izazovi na koje bi stvaratelji i arhivi trebali odgovoriti.In recent years, Croatian institutions responsible for the production/accumulation of records have begun utilizing digitally-stored records and digitised records on a large scale. They have also moved from filing systems toward document management systems, records management systems or enterprise content management systems. The implementation of document/records/enterprise content management systems is not a trivial change for an organisation if we consider the integration of such systems with existing databases and other solutions related to records management practice. The typical results of the implementation of a new digital environment (besides the increasing new advantages) are new challenges for the records creator and the archive that supervise it. This article addresses such business and recordkeeping advantages and challenges

Four Aspects of the Explicated Constitution

Ovim se radom odstupanje Šulekovog Ustava od uobičajenog pravnog diskursa dovodi u odnos s ulogom koju je tekst imao u konstrukciji pojma hrvatske nacionalnosti. Konstitucija je proizvod nekoliko drugotnih modelativnih sustava zbog predviđene recepcije teksta i ugradnje prava u kulturu. Usporedno s ostalim nacionalnim kulturama u Monarhiji, pravno osnaženom kulturom se nastojalo ujediniti zajednice na ovim prostorima, što je postupak koji se pokušava sagledati kroz nekoliko aspekata teksta. Aspekti Konstitucije međusobno su povezani zbog nemogućnosti isključivog razlikovanja izraza i sadržaja u drugotnim modelativnim sustavima. Transkulturni aspekt prikazuje zamišljeni osnutak prava u “pučkoj razboritosti” koja je retoričkim sredstvima prikazana neovisnom o onim kulturama što se nastoje zamijeniti modernom pravnom kulturom. Kulturni aspekt sadrži značenja bitna za tvorbu nacionalnog identiteta. S obzirom na jezik i recepciju teksta, mogu se uočiti pripovjedno-povijesni i indikativno-normativni aspekti. Pripovjedno-povijesni aspekt se sastoji od pravila pripovijedanja i posredovanja povijesnog iskustva, a sadrži pripovjedača i potencijalne ili uzorne junake. Cilj ovog dijela Konstitucije je bio osigurati da buduća pravna kultura ne bude suviše udaljena od svojih primatelja, te da se prihvatljivo uvedu pravne norme. Norme i indikativni opisi dani su posljednjim aspektom.This study relates the aberrations of Sulek’s constitution from the ordinary legal discourse to the role the text had in constructing the notion of Croatian nationality. Due to the anticipated reception of the text and the incorporation of law into culture, the constitution is a product of several secondary modeling systems. As well as in the other Monarchy’s national cultures, the legal strengthening of the Croatian culture was an attempt to unite the communities in the area. This procedure is examined through several aspects of the text. As the form and content cannot be separated in the secondary modeling systems, the aspects of the constitution are interrelated. The transcultural aspect delineates the imagined founding of law in the “folk prudence”, which is rhetorically represented as independent of cultures which are to be replaced by the modern legal culture. The cultural aspect consists of meanings relevant for the constitution of national identity. Related to the language and the reception of the text are the narrative-historical and the indicative- normative aspects. The narrative-historical aspect consists of the narrative rules and rendering of the historical experience, and includes a narrator and potential or exemplary heroes. The goal of this part of the constitution was to bring the future legal culture closer to its recipients and to introduce the legal norms in an acceptable way. The final aspect is concerned with the norms and indicative descriptions

Different Environments, Same Profession: Potential Application of it for Computer Generated Archival Description in the Archives

Autor razmatra različite IT alate u obradi registraturnog i arhivskog gradiva polazeći od procesa s gradivom, bez obzira na to odvijaju li se oni u primarnoj okolini stvaratelja gradiva ili u sekundarnoj okolini nadležnog arhiva. Oslanja se na model kontinuuma zapisa, zaključak o struci T. Thomassena i propitivanje mogućnosti korištenja IT alata za opis D. Kušena. Rad se nastavlja na prethodno izrađenu komparativnu analizu sustava za upravljanje arhivskim gradivom, no u središtu je pažnje sama funkcionalnost računalne izrade opisa gradiva bez obzira na vrstu IT alata. Autor raspravlja o početnim problemima i propituje mogućnost i smisao primjene generiranja opisa gradiva iz aplikacija te analizira zahtjev za računalno generiranim opisom na primjeru organizacije u kojoj radi.Author considers application of different IT tools for processing of current and archival records. Author’s starting point is archival processing no matter where it occurs – in the primary environment of records creator or in the secondary environment of archival institution. Article relies on conclusions arising from records continuum model and T. Thomassen and D. Kusen writings. In the article, author focuses on development of computer generated archival description functionality of different IT tools in archives. Author discusses initial problems, examines possibilities and relevance of this functionality, and analyses user requirements on the example of particular records creator

Vrednovanje arhivskoga gradiva: Analiza arhivske vrijednosti i utjecaj na obradu i korištenje gradiva

Cilj. Ovim radom, nakon objašnjenja gradiva i postupaka nad arhivskim gradivom, autor želi objasniti pojmove vrednovanja gradiva, prikazati katalog arhivskih vrijednosti i dekonstruirati odnos arhivskoga gradiva i događaja, povijesti, identiteta i drugih označenika vrijednosti gradiva. Vrijednost gradiva autor sagledava u okviru interpretativnog semiotičkog mehanizma korištenja arhivskoga gradiva u kojem ta vrijednost usmjerava korisnikovu interpretaciju prema raznim označenicima i tvori lance suplemenata te otvara prostor za korištenje, razumijevanje i prihvaćanje gradiva. Pristup/metodologija/dizajn. U radu se razmatraju određenja arhivskoga gradiva, vrednovanja i vrijednosti arhivskoga gradiva te postupci obrade arhivskoga gradiva. Autor stavlja postupke vrednovanja, uništavanja, akvizicije i odbacivanja gradiva, sređivanja i opisa gradiva u međusoban odnos, kritički koristeći arhivističku literaturu i tercijarne izvore. Za obrazloženje pojma vrijednosti te dekonstrukciju i semiotičku analizu pojma gradiva, autor koristi literaturu iz područja antropologije, arhivistike, dekonstrukcije, lingvistike, logike i semiotike. Rezultati. U radu se objašnjava postupak vrednovanja arhivskoga gradiva, njegove veze s drugim postupcima nad arhivskim gradivom, defi nira i katalogizira pojam vrijednosti arhivskoga gradiva, dekonstruiraju mogući odnosi vrednovanog arhivskog gradiva s korištenjem te ukazuje na mehanizam semiotike arhivskoga gradiva kao znaka. Originalnost/vrijednost. Izvornost rada očituje se u dodatnom pogledu na definicije arhivističkih postupaka, na arhivsko gradivo i njegov interpretativni potencijal – prema vrijednosti koje ono ima za različita korištenja i za različite korisnike

Postmodern archival science: introductory questions

Ovaj članak obrazlaže odnose postmodernosti i arhivistike u teoriji i svakodnevnom radu na kulturnim materijalima u širem smislu. Što je postmoderna i koja su moguća arhivistička stajališta prema njoj? Prikazuju se teze najrelevantnijih autora uz komentar polazišta, argumentacije i znanstvenog utemeljenja suvremenoga tržišta ideja te se potiču određena pitanja iz arhivističke perspektive. Člankom se ukazuje na odnos postmoderniteta spram moderne znanosti, epistemološke tradicije i prijašnjih pokušaja legitimacije znanja. Prva cjelina pokazuje konstrukciju moderne arhivistike, druga cjelina obuhvaća implikacije njezinih načela, a treća je cjelina orijentirana na današnju legitimaciju institucija. Svaka cjelina predlaže drugačije pristupe od trenutno dominantnih. Poznavanje utjecaja moći omogućuje propitivanje uloge arhiva u suvremenom društvu i mjesta arhivistike u sustavu znanosti. Svijest o epistemološkoj izgrađenosti načela potiče drugačije razumijevanje utvrđenih jedinica te skreće pažnju arhivista prema gradivu kao kulturnom znaku koji se tumači iz suvremenih okolnosti. Konačno, naznačena je mogućnost vlastite legitimacije diskursa i utemeljenja politike arhiva usporedno s raspoloživim tehnologijama. Postmoderna promatra arhive u njihovoj suvremenosti.The basic intention of this article is to show relations between postmodern thought and archival science, through its theoretical presumptions and practical inurements. In concordance with the formulations of impossible introduction (in Curtius sense) used in many texts before, it is hard to epitomize a great number of paradigmatic courses in current Theory, especially in the text which is in a pursuit of recent theoretical implications on today\u27s archives as important scientific and social institutions. First of all, article gathers information about postmodernism which leads us to dissimilar comprehensions of the term and further various outlines. After a short review of some ideas from different aspects, this paper raises a question about connections among postmodernism, modernism, tradition and contemporarity according to its cultural establishment and possible political uses of technology. For the purpose of that three relevant authors (and three approaches to our hereditary traint for knowledge, tradition and technology) have been consulted in order to describe function of archival scientific discourse, proceedings with archival items according to some metaphorical concepts that lie beneath scientific methods and problem of legitimation of science. Can it be achieved through the influence of technology or is it that the same technology is a part of a broad cultural sphere? Foucault informed scientists about them being dependent on power and its own strategies in which scientific discourse is polyvalent tactics. The thought of the archives as a part of the government and transgressive places at the same time can be widened according to Foucault\u27s ideas of complex social strategies and archival notions of a new kind of governance. Considering relations between archives, its discourse and power, it is obvious that the main tasks of archival science have changed: historical research is no longer the only goal and the concept of history itself has altered. Structures that enable scientific knowledge are contradictive according to Derrida. In the center of structure often lies the external idea which operates traditional devices and rhetoric. The deconstruction of these instruments enables us to focus on the other part of binary opposition between records creator and records. Nevertheless, we are working with texts, with records which were considered as mere supplements. It would not be exaggerated to say that archives are multicultural destination points… if so, their objects must be cultural signs and that implies some new approaches in records analysis and interpretation. What kind of the semiotic model of a sign can be applied on archives and what can be achieved by using this approach? The shifts from the classical representational sign toward derridian marque and Peirce’s interpretant have consequences on appraisal and relationship between record and creator. These two issues are related with archival practice. What happens with social role of the archivists when they become interprets of cultural legacy? Lyotard searched for new legitimating principles of scientific discourses in the time distrustful of great narrations such as emancipation and progress. Instead of legitimating through performance, he suggested real co-existence of many scientific world descriptions. This assumed at least two consequences: technology can affect archives only as a part of a wider political condition and, second, no other external ethical, political or any language can legitimate archival science as its own discourse can. This can provide an un-doubtful autonomy for archival practice. Paralogical legitimation of the archives as cultural institutions of different communities can be achieved only in social context what actualizes broader understanding of archives. Postmodernism can juxtapose autonomy of archival science with plurality of interpretations of archives. The purpose of this article is to ask certain questions and initiate some new approaches not just because there is a bad time for solid solutions, but because the only possible way to establish Archive as an institution of today can be found through discussion

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"