Case Studies

Background

Fresenius Kabi is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Within I.V. generic drugs, Fresenius Kabi counts among the leading suppliers, in particular in the U.S. market. As with all large pharmaceutical companies, the Corporate Regulatory Affairs Department of Fresenius Kabi was looking for a modern tool for the management of its product licenses wide product portfolio.

Requirements

The Corporate Regulatory Affairs Department of Fresenius Kabi initiated a review of their existing systems to determine how they were supporting their regulatory affairs globally. The objective was to establish what the incumbent systems provided and where the gaps were in relation to their actual needs.

The review established a number of key requirements.

• The system needed to be globally deployed using a single, secure database;
• The system needed to be user-friendly and include data from all affiliates;
• The system needed to provide a worldwide view and data management by all regulatory activities, including the current status of all products and licences;
• The system needed to offer an effective method of reporting, Management, internal departments and affiliates;
• The system needed to offer advanced notifications (Alert function)
• The system should fit into the existing IT framework.

It was also essential that the new system provided a high level of flexibility for managing different regions, product groups, supply chain partners, etc. Fresenius Kabi operates across multiple time zones and regions and they required a common method of working for all users and affiliates. With numerous key regulatory activities occurring in each calendar year for any particular product, it was essential to have complete detailed overview and follow-up of all deadlines and milestones - with advanced notification (Alert function).

Fresenius Kabi spent several months researching regulatory systems, before short-listing four potentially suitable applications. The short list was based on best fit and cost. Following more detailed assessment, demonstrations and discussions with vendors, Fresenius Kabi selected Samarind RMS (regulatory management software) as a very good potential solution, and agreed to test the Samarind software via a pilot of the system. This approach allowed Fresenius Kabi's regulatory team to thoroughly test the application against its defined user requirements, prior to purchase.

Aside from determining the suitability of Samarind RMS for their end users, Fresenius Kabi needed to be sure that Samarind RMS would fit within its corporate IT infrastructure. With a large operation like Fresenius Kabi the technical aspect of deploying Samarind RMS was critical e.g. future updates needed to be provided unilaterally.

Jens Klokkers, Project Manager for Fresenius Netcare commented, "It was essential that any application deployed would need to fit within our existing IT framework. This included the ability to access the system from any one of Fresenius Kabi's satellite locations around the globe. It was a pre-requisite that all users could access the system using our existing network infrastructure and security protocols. Together with Fresenius Netcare, Samarind ensured that the system fitted into our framework seamlessly, and without the need to incur additional overhead. The project implementation was very straight forward and Samarind were always a pleasure to deal with. They communicated very effectively with us at all stages throughout the project."

Solution

Samarind RMS was deployed using a single site, single server installation, with users from around the world taking part in the pilot/test phase. This was especially useful for the Fresenius Kabi Deutschland GmbH regulatory management team, because it enabled them to further develop their operational processes based on tangible user feedback and other information gained from using Samarind RMS.

It was imperative that each regional 'user group' only had access to change information when and if it was applicable to them, whilst also being able to read/view information on a strictly need to know basis. Samarind RMS provided this flexibility enabling the Fresenius Kabi teams to work more effectively, whilst giving the senior management team access to time critical information, either at a glance, or through the system generated notifications, alerts and reports.

Dr. Dr. Michel Mikhail, Senior Vice President of Corporate Regulatory Affairs at Fresenius Kabi Deutschland GmbH commented, "With a large portfolio of products we needed a modern and flexible software system to cope with all of the variables and the worldwide diversified portfolio. We are very impressed with Samarind's openness to our needs and our worldwide portfolio, their willingness to work in partnership with Fresenius Kabi global regulatory and IT teams to ensure our needs are met precisely."

Outcome

The successful implementation of Samarind RMS means that Fresenius Kabi now has a validated global regulatory affairs database. The deployment has greatly reduced the time to view critical information for all stakeholders and affiliates globally. It has also helped Fresenius Kabi to streamline its operational processes by avoiding managing data in different Excel sheets.

All key deadlines and time critical tasks are met, through configurable automated, system-generated alerts. Regulatory tasks such as applications for a new Marketing Authorization, Variations and Renewals are completed much more quickly due to more consistent and streamlined processes.Overall Samarind RMS has provided  a compliant structured toolset, with which Fresenius Kabi is able to manage the lifecycle of its licence portfolio.

 Dr. Gabriele Schriever, Regulatory Affairs Manager at Fresenius Kabi Deutschland GmbH commented, "Once we committed to working with Samarind we could see that most of our needs could be realised. Throughout the pilot, their input helped us to fine-tune our requirements with a positive effect. All users are very happy with the system and it has been easily accepted worldwide. As a result we now have a much better validated global regulatory data base / tracking system and more efficient access to registration data."

Samarind's Software Director, Miranda Pothiawala commented "We're enormously proud to have been first choice to supply Fresenius Kabi's global regulatory tracking system. Samarind RMS will support users in over one hundred countries from a single server installation, which demonstrates its credentials as a genuine world-class software product."

"This latest success gives our whole team great confidence to push Samarind further ahead in producing world-class regulatory affairs software. Working with Fresenius Kabi has been an absolute pleasure throughout the entire project and we look forward to a long lasting and successful partnership with them in the years ahead."

© Samarind Limited 2010

For further information about Samarind RMS please contact:

Phil Turner
Samarind Limited
Parkway Business Centre
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Deeside Industrial Park
Flintshire
CH5 2LE
UK
Tel: +44 (0) 1244 288281
Fax: +44 (0)1244 288820