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GTI succeeded in winning the Analytisches
Zentrum Biopharm in Berlin, a prestigious
contract research institute for the pharmaceutical
and chemical industry, as pilot customer
for the new LIMS, SOTHIS. Here, the system will initially
be used at 12 workstations, but is open
to unlimited expansion at a later time.
Our in-depth project supervision includes
the preparation of all life cycle documents
required for the system validation and
audits (e.g. software design specification,
risk analysis on the developer side, software
test protocols and change control protocols),
as well as the support of the validation
measures on the operator side (e.g. setting
up validation master plans and SOPs).
Highlights of SOTHIS
include the computer-guided feedback of analytic
results, the automatic generating of test
orders during sample posting or according
to a test schedule on file, an integrated
goods economy system (purchases/sales, warehouse
management), GxP-compliant data security
(rights management, audit trail, electronic
signature), as well as the managing and calling
of any document via the directly interlinked
DMS (including the expansion option “PharAO”).
Please request more information
on SOTHIS.
Scarabaeus Release
05.00.0007: Substantially Improved Production
Planning
