info
review
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portal CALIMS. Svi podsistemi su usko in-
tegrisani sa Informacionim sistemom razvi-
jenim kroz prvu fazu projekta, u cilju konti-
nuiteta poslovnih procesa. Pored nabrojanih
softverskih rjesenja druga faza obuhvatala
je i nabavku i instalaciju neophodnog hard-
vera za funkcionisanje Informacionog
sistema koji smo obezbijedili iz IPA fonda.
Druga faza razvoja Informacionog sistema
zavrsena je uspjesno i pustena u produkcio-
ni rad u oktobru 2012 od kada se uspjesno
koristi u svim poslovnim procesima Agen-
cije. S obzirom na nacin pristupa izrade i
implementacije Informacionog sistema i
na cinjenicu da ovakav integralni informa-
cioni sistem ne postoji ni u jednoj Agenciji
za ljekove u zemljama regiona, a ni u dosta
Agencija u zemljama EU, nase opredjeljenje
je bilo da razvijamo namjenski informacioni
sistem koji e u potpunosti biti prilagoen
nasim poslovnim procesima. Iz tog razloga,
(eDMS), management of eCTD documents
for medicines registration and the web portal
CALIMS. All subsystems are closely integrated
into the Information system developed through
the first phase of the project, with the aim of
achieving continuity of business processes. In
addition to the listed software solutions, the
second phase also included the procurement
and installation of necessary hardware for
Information system, resources for which we
acquired via the IPA fund. The second phase
of the Information system development was
concluded successfully and commissioned in
October 2012, and since then, it has been used
successfully in all business processes of the
Agency. Given the approach to the construction
and implementation of the Information system
and the fact that this integrated information
system does not exist in any of the medicine
agencies in the region or many agencies in
the EU countries, we decided to develop a
dedicated information system which will fully
be adapted to our business processes. For that
reason, all te system components, apart from
the ERP, were specially developed according
to the business needs of the Agency. Data
exchange, i.e. application of the same data
among system components reduces the need for
administrative resources and reduces human
errors which truly bring to achieving better
performances when talking about business
processes. All business processes which are
related to processing users' queries or to
work on internal cases (project management,
quality system documents management, and
similar), are performed through the "workflow"
component which was developed within the
eDMS system. This component monitors the
flow of business processes and activates other
information system modules.
The Information system of CALIMS is
connected with the web portal which includes
three components: public portal which presents
public data as the result of business processes;
secured portal for clients who can check the
case status and submit new requests by filling
in e-forms; electronic commission meeting for
medicines registration which is also a secured
part of the portal which can be accessed
only by the members of the commission
for medicines registration with the aim of
downloading documents for commission work
and submitting reviews.
sve komponente sistema, osim ERP-a, su
namjenski razvijane prema poslovnim pro-
cesima Agencije. Razmjena podataka, to
jest korisenje istih podataka, izmeu kom-
ponenti sistema umanjuje nam potrebu za
administrativnim kapacitetima i smanjuje
greske u radu sto istinski dovodi do posti-
zanja boljih performansi poslovnih pro-
cesa. Svi poslovni procesi koji se ticu obrade
zahtjeva korisnika, ili pak rada na internim
predmetima (voenje projekata, upravlja-
nje dokumentacijom sistema kvaliteta i sl.),
obavljaju se preko komponente "workflow"
koja je izraena u okviru eDMS-a. Ova kom-