2 declaration of conformity – software validation, 3 ordering designations – Metrohm IC Net 2.3 User Manual

Page 372

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11 Appendix

IC Net 2.3

362

11.2

Declaration of conformity – Software

validation

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 Ordering

designations

6.6034.033

«

IC Net 2.3» Software

incl. «IC Net 2.3» , «IC Cap 2.2» and
«

Autodatabase 1.0» software

8.102.0043

«

IC Net 2.3» Software Manual

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

8.110.8213

«

Autodatabase 1.0» Software Manual

8.110.8207 Registration

card

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