VIQ-Installation-Qualification
Version 2 .1 Page
1/3
Installation Qualification (IQ)
Definition of the Installation Qualification
The qualification document „Installation Qualification (IQ)“ is part of the quality management system at the
company KNAUER Wissenschaftliche Geräte GmbH .
Scope
The customer can request the Installation Qualification . In case of a request, the Technical Support of KNAUER or a
provider authorized by KNAUER performs this functionality test during the installation . The IQ is a standardized
document and includes the following:
Confirmation of flawless condition at delivery
Check if the delivery is complete
Certification on the functionality of the device
Instructions
Any deviations to the specifications and problems encountered during installation have to be recorded as comments
in the document . In addition, all courses of action undertaken to resolve the problems and remove the deviations
have to be recorded as comments in the section „Comments/recommendations“ .
If certain items in the report are not applicable, this has to be indicated by ‘n/a’ (not applicable) in the table . Larger
sections that are not used have to be crossed out (diagonal line through them), marked with ‘n/a’ and date
(DD-MM-YYYY) and signed .
All required documents have to be completed during the installation (of the system) .
The document will be reviewed by a person authorized by the laboratory director . The inspection must be
documented with the date of the inspection (DD-MM-YYYY) .
The tests have to be carried out in a suitable environment as described in the instructions of the device .
About this document
The information in this document is subject to change without prior notice . This document may not be used,
reproduced or translated without written consent of KNAUER Wissenschaftliche Geräte GmbH .
Depending on the customer’s quality assurance system, the signed document either has to be filed in the device
folder or scanned and stored in an electronic archive .
Device name
Product number
Serial number
Firmware version:
Location
Manufacturer/
supplier
KNAUER Wissenschaftliche Geräte GmbH
Hegauer Weg 38, 14163 Berlin
Phone : +49 30 809727-111
E-Mail: support@knauer .net
KNAUER agent
Customer
Customer number
Company
Contact person
Address
Postal code
City
Phone
Location
Place of installation
Device data
Customer data
Содержание BlueShadow Detector 40D
Страница 1: ...Detector 40D Instructions Document no V7647 HPLC HPLC...
Страница 71: ...Appendix Installation Qualification IQ...