GTI,
the Brandenburg-based software house, will
present a first time ever pre-release of
its new “Pharmaceutical ERP” Scarabaeus
AX, based on Microsoft Dynamics™ AX , at this year’s
Cebit. With this premiere, GTI will introduce
the technological successor to the existing
ERP solution “Scarabaeus+”,
which has been continuously optimized to
meet the need of small and mid-sized pharmaceutical
businesses since development began in 1991.
Scarabaeus AX will implement the transfer
of a proven industry solution onto the future-oriented
platform of a global player. Aside from pharmaceutical
manufacturers, Scarabaeus AX will also address
the needs of small and mid-sized business
in the pharmaceutical industry, such as bio
technology and cosmetics.
Scarabaeus AX offers a range of functions that will
leave nothing to be desired: Complete financial management,
supply chain management (PPS / MES + logistics), quality
control including all LIMS functions, CRM, business
intelligence (reports and evaluations), human resource
management, and much more, such as an interface to
GTI’s pharmaceutical document management system
PharAO. Thanks to the innovative three-tier solution,
there will be virtually no limit to the up-scaling
of the number of users and the networking of remote
locations under a central database; naturally, options
include also the management of any number of clients
(“multi client capability”) and the global
online access to system data. Yet there are other ways
in which Scarabaeus AX “transcends boundaries”.
Users select their own interface language (the default
being German, English, French or Spanish), and can
moreover—provided they own the access rights—adapt
the processing views to their own requirements.
Despite all its flexibility, Scarabaeus AX will yet
be fully GMP compliant in regard to the development
and documentation, and thus fully validation-enabled,
just like its historic version. This includes a complete
documentation of the entire development- and life cycle
of Scarabaeus AX. The GTI quality management system
ensures active version management and controlled change
management. Any documents required for the software
validation at the operator’s location will be
available through GTI. The source code will be included
in the package.
Even as far as functionality goes, Scarabaeus AX is
GMP compliant. This way, access to the system data
is subject to user-specific control through the rights
system, except for the field and data record level.
In addition, action-dependent electronic signatures
can be forced, as mandated by the FDA in accordance
with 21 CFR Part 11, and activate a complete audit
trail functionality. Each change of data can be automatically
historicised, and the entire change history can be
edited for the sake of inspections, using an integral
evaluation tool. Naturally, consistent batch tracking
is guaranteed.
|
