1 authorization and responsibilities, 1 documents and procedures – K-Patents PR-23 for K-Patents User Manual

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Onsite Qualification Protocols and

Records: Installation Qualification

This Installation Qualification (IQ) involves documented verification of the complete
system: K-Patents Pharma Refractometer PR-23-AC with Ethernet connection and
Laboratory Test Cuvette LTC, as installed and connected to a thermostatic bath and a
computer in laboratory, and in compliance with the approved design, the manufacturer’s
recommendations and user requirements.

7.1 Authorization and responsibilities

7.1.1 Documents and procedures

The following documents and procedures are inspected:

● Scope and procedure for qualification

● Report on Installation Qualification

● Protocol for Installation Qualification

The authorized official (client) hereby declares that the execution of the Installation
Qualification (IQ) for the Pharma Refractometer and Laboratory Cuvette LTC have been
approved in accordance with this document/log. The authorized official is responsible for all
relevant matters in regard to the installation qualification.

Release by superior department:

Name:

Function:

Date:

Signature:

Initials:

Authorization by a higher-level authority is a prerequisite for carrying out the
qualification procedure. If no valid written authorization is available: Terminate the
Installation Qualification.