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Cimage Solution Manages eProcesses & Documents in
Research and Manufacturing at Byk Gulden
Byk Gulden (http://www.byk-gulden.com), the
pharmaceuticals division of the Altana group, is an international researching
pharmaceutical company based in Konstanz, Germany, with over 6,400 employees and
28 subsidiaries worldwide. The company specialises in the field of therapeutics
and conducts its own research – an approach which secures the company's
excellent world-wide market position sales of more than billion euros in 2000.
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"Cimage was able to provide a solution that could help us achieve our
mission-critical goals." |
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Gulden constantly reviews its systems and processes in order to maintain
its competitiveness. With increasing global competition and stringent
regulatory pressures, the company recognises that it to maintain fully
records and complete research and manufacturing processes. When applying for
new product approvals, a large number of documents must be provided to the
drug regulators. In order to manage document workflows within the drug
regulatory submission chain and to comply with related guidelines in Europe
and the USA, such as FDA 21 CFR Part 11, the company decided to implement an
information management solution. |
INCREASING WORKFLOW EFFICIENCY AND REGULATORY COMPLIANCE
In 1999 Dr. Ruediger Buchkremer, head of Byk Gulden's Department of
Information and Documentation, took charge of the project to find a supplier to
provide the workflow and audit functionality required to meet the new challenges
that the company was facing. Above all, he wanted to reduce the risk of
procedures not complying with regulatory guidelines.
Following an intensive evaluation programme and visits to reference
sites, the company chose Cimage's solution for the pharmaceutical
industry.
Dr. Buchkremer explains: "We were looking for a solution that would enforce
regulatory compliance with integrated workflow processes – and meet the
stringent requirements for electronic signature as stipulated in 21 CFR Part 11.
Cimage was able to provide a solution that could help us achieve our
mission-critical goals."
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Byk Gulden offices, Konstanz, Germany
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"The
degree of customisation required for document management processes with
Cimage was minimal." |
MINIMAL CUSTOMISATION
Cimage's NovaManage solution was based on the company's many years
of experience in the pharmaceutical industry, providing customisable data models
and user interfaces as well as controlled printing templates pre-configured for
the specific requirements and terminology of FDA regulated industries. It could
also demonstrate a track record of successful implementations.
According to Dr. Buchkremer: "The degree of
customisation required for document management processes with Cimage
was minimal. This was a major consideration for us, because it enabled us to
implement quickly and at a lower cost. In addition, the standard components of
NovaManage such as "logical documents"
are used without modification to develop complex applications like the
generation of study reports. (In NovaManage, a logical document is a set of
files of any type that are grouped together like the chapters of a book).
Revision control can be applied at the logical document level, so you have the
right version of every component document. The controlled documents of
NovaManage are made available in a submission management system for the dossier
compilation."
Updating and maintaining information is simplified using electronic mark-up
and routing of documentation, thereby ensuring reviews and amendments are
streamlined. Because the system enforces compliance, the risk of errors is
reduced and compliance costs are controlled.
PROVEN 21 CFR PART 11 COMPLIANCE
Crucially the system verifies that the approvals are valid and that documents
are signed by the right people - even when they are being signed simultaneously
in different locations. The workflows are handled completely electronically with
the electronic signature included. This helps to reduce the time taken to obtain
multiple (international) document approvals and has been independently audited
for FDA 21 CFR Part 11 compliance.
AHEAD IN THE PHARMACEUTICAL RESEARCH FIELD
Based on an Oracle client-server database environment, installation of the
new system commenced in September 1999. Within a year the system was validated
and ready to use across a number of departments working within a regulated
environment, including some who were accessing information from different
countries.
Dr. Buchkremer comments: "Cimage NovaSoft's
graphical workflow makes it very easy to use so we were quickly up and running."
Dr. Buchkremer concludes: "Electronic workflow
processes are not yet used widely in pharmaceutical research. Cimage NovaSoft's
solution addresses our regulatory compliance needs at a time when the industry
is just beginning to realise the benefits of digital workflow. It not only makes
us more efficient, it really puts us ahead of the field."
LOOKING TO THE FUTURE
The initial Cimage NovaSoft project was completed on time and to schedule.
Sibylle Teuchmann (Project Leader) is managing a follow-up project to roll out
the new electronic processes more widely in the areas of research and
manufacturing. The first phase of the project is a planned upgrade to the latest
version of NovaManage for Windows 2000. Also under consideration are
improvements to the document review processes (redlining), implementing
hyperlinks between individual documents and using NovaManage's web integration
facilities for document search and workflow.
Byk Gulden research and administration, Konstanz, Germany
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