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NEWS

Aug 31

2nd Successful eCTD Lifecycle Management, 14 - 15 September 2010, Prague

We are happy to inform you that one of the Infotehna customer JSC Grindeks will participate at the 2nd Successful eCTD...
Jul 14

Innovation award

On 3th of July on Otočec the third presentation of innovation awards given by Chamber of Commerce Dolenjska and Bela...
Jul 14

INFOTEHNA expands again

Right on the first day of summer, on 21st of June, we registered another subsidiary company. Our German subsidiary,...

EVENTS

Aug 25

Infotehna GmbH GRAND OPENING with workshop, Garching/Munich, Germany, September 23, 2010

            Infotehna Group is kindly inviting you to the Infotehna GmbH GRAND OPENING with workshop on 23...
Jul 30

EU Gateway Business Mission, Tokyo, Japan, 13 – 17 September 2010

We are pleased to announce that Infotehna will participate at the EU Gateway Business Mission, which will take place...
Jul 30

6th Annual Achieving Quality & Process Excellence in the Pharmaceutical Industry, Lisbon, Portugal, 15 – 17 September 2010

We are pleased to announce that Infotehna will have presentation at the 6th Annual Achieving Quality & Process...

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PLIVA

pliva logo

PLIVA is a global generics company and is currently the leading pharmaceutical company based in Central and Eastern Europe (CEE).
Distinguishing itself from its generic pharmaceutical competitors, PLIVA is one of few companies with a strong scientific development base – built upon innovative science. With nearly forty years since its first FDA approval and as the originator of azithromycin, PLIVA has a strong history in both the highly demanding and rigorous, quality and regulatory environments of the USA and Western Europe. PLIVA’s manufacturing facilities are all FDA and/or MHRA approved and are concentrated in the cost competitive countries of CEE. 

More about Pliva

PLIVA and Infotehna started developing a business application nine years ago, which eventually became GLORYA. Both companies approached the task with much enthusiasm and only a few had knowledge of the difficulties that were in front of us. Today, when we look back to the road we have covered, we can only be proud of the excellent work we have taken part in. We have an application 100% tailored to our needs, and what more importantly, the application has been endorsed by quite a number of other important pharmaceutical companies worldwide. All this would never have been possible without the excellent co-operation we have had with Infotehna over all these years. They have far exceeded the original scope of the project in order to reach the level of performance we were both striving for.

Since cut-over performed 25-27th October 2003, more than 500 users are actively working on the system in Development, QA/QC, Production and Regulatory Affairs department.

"Successful implementation enables speeding-up & integration of overall process of regulated documentation management, from daily business operations to CTD compilation. Using the latest technology we have created system compliant with CFR21 part 11 that is user friendly and at the same time powerful & flexible. Over the next year we are planning significant extension of application usage on the global scale".  

Marijo Volarević, M.Sc.E.E Corporate IT - Head of Corporate End-User Support  


"PLIVA and Infotehna started developing a business application nine years ago, which eventually became GLORYA. Both companies approached the task with much enthusiasm and only a few had knowledge of the difficulties that were in front of us. Today, when we look back to the road we have covered, we can only be proud of the excellent work we have taken part in. We have an application 100% tailored to our needs, and what more importantly, the application has been endorsed by quite a number of other important pharmaceutical companies worldwide. All this would never have been possible without the excellent co-operation we have had with Infotehna over all these years. They have far exceeded the original scope of the project in order to reach the level of performance we were both striving for."

Brigita Coric,  Central Regulatory Affairs, USA registrations

"Pliva has been using myProcess - Infotehna's solution for document management since 2003. With over 1100 users at 6 sites and over 1000 new documents created weekly, Infotehna's application enabled us to increase the level of compliance and decrease time-to-dossier.  Switching from paper to electronic document management system, we are successfully managing the increased workload and fulfilling more demanding regulatory requirements.

Infotehna is a reliable partner who is promptly and professionally supporting Pliva with any new request that we might have."

Marija Uglešić, PLIVA GxP EDMS Service Manager

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