2 konformitätserklärung – softwarevalidierung, 3 lieferumfang – Metrohm IC Net 2.3 Benutzerhandbuch
Seite 375

11.2 Konformitätserklärung – Softwarevalidierung
IC Net 2.3
365
11.2
Konformitätserklärung – Software-
validierung
The software "Metrodata IC Net 2.3" was developed in accor-
dance with the requirements of the ISO 9001 quality system re-
garding the design, testing and servicing of Metrodata software.
The relevant procedures are described in the document "Project
procedure for creating Metrodata software" which is available at
your Metrohm agency on request.
The software was validated with respect to functionality, analytical
performance and accuracy of results. The technical specifications
and software functions are described in the Instructions for Use.
Herisau, October 5, 2005
D. Strohm
Ch. Buchmann
Vice President
Vice President
Head of R&D
Head of Production
Responsible for Quality Assurance
11.3 Lieferumfang
6.6034.033
«
IC Net 2.3» Software
inkl. Software «IC Net 2.3» , «IC Cap 2.2» und
«
Autodatabase 1.0»
8.102.0021
«
IC Net 2.3» Software-
Gebrauchsanweisung
8.110.8293 Using
«
IC Net 2.3» Software to comply with
21 CFR Part 11
8.102.1013
«
IC Cap 2.2» Administrator Manual
8.102.1119
«
IC Cap 2.2» User Manual
8.110.8211
«
Autodatabase 1.0» Software-
Gebrauchsanweisung
8.110.8207 Registrierkarte