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GMP-Audits at GTI/ Excerpts from the Auditing
Report
- Analytical Centre Biopharm GmbH Berlin:
“ The
company GTI presents itself as a professionally set-up and innovative
business in the area of pharmaceutical software solutions. All test
areas are well or superbly documented, contributing to the positive
overall
impression. The processes within the business are clearly defined and
structured. Each process flow is segmented, and can be displayed in
a clearly intelligible way. GTI complies fully with the internationally
relevant standards and regulatory catalogues that have been defined
for
all businesses developing software solutions for the pharmaceutical
industries and laboratories.”
Conclusion: “The company GTI is pronounced a fully qualified SOTHIS
vendor for the AZ Biopharm analysis centre.”
- Lindopharm GmbH:
" On occasion of the audit conducted
at the company GTI, Stahnsdorf, inspections focused on the following
test areas, in compliance with SOP IT 1115: quality management, system
development life cycle, developing and programming standards, system
documentation, testing of system modules, [...]. In summary, the company
GTI, Stahnsdorf, complies with the quality standards required by the
company Lindopharm GmbH from vendors of computer-aided systems. The
initial positive impression was confirmed by the vendor audit."
- Mibe GmbH Pharmaceuticals:
“ In sum it is stated that
GTI GmbH is fit, on the basis of its quality management concept, to
serve as supplier of a GxP-relevant system for Mibe GmbH.”
- PenCef Pharma GmbH:
“ We hereby state that the company
GTI is fit to deliver and install pharmaceutical software.”
- Temmler Pharma GmbH & CO. KG:
“ The company
GTI possesses a functional quality management system. […] On
the basis of the present audit, there are no major reservations against
the
delivery of a ERP system to Temmler Pharma by GTI.”
- Pharmaceutical Factory Evers & Co. GmbH:
“ […]
in conclusion of the inspection, performed by our expert Herr Fischer,
we would like to inform you that Scarabaeus+, including CAP, is released
for delivery.”
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Quality Management
- http://www.apv-mainz.de (cooperation
for pharmaceutical processing technology): among other things, with
the "APV Guideline for Computer Aided Systems Based on Annex 11 of the EU-GMP Guideline."
- http://www.fda.gov
(Food and Drug Administration of the U.S. Department of Health and Human
Services): Website of the US licensing authority for medicines, products
in medical technology, cosmetics, veterinary medicine, or food additives.
- http://www.ispe.org (International
Society for Pharmaceutical Engineering): "ISPE,
the International Society for Pharmaceutical Engineering, is a world-wide,
non-profit volunteer society of technical professionals who apply
their practical knowledge in the pharmaceutical industries. ISPE is committed
to the advancement of the educational and technical efficiency of
its members through forums for the exchange of ideas and practical experience."
- http://pharmacos.eudra.org (Website
of the "Enterprise Directorate-General" of the European
Commission): It concerns itself among other things with the legal
regulations of the pharmaceutical market.
- http://www.gmp-navigator.com (Concept
Heidelberg) "Conferences & Consulting on GMP and Regulatory
Affairs"
- http://www.bmgs.bund.de
(Federal German Department for Health and Social Security) : It contains
among other things an extensive compilation of applicable laws.
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