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

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This Installation Qualification (IQ) involves documented verification of the complete system:
K-Patents Pharma Refractometer PR-23-AC and Pharma Mini flow cell PMFC-HSS with
Ethernet connection, as installed and connected to a fractionation unit and a computer,
and in compliance with the approved design, the manufacturer’s recommendations and
user requirements.

6.1 Authorization and responsibilities

6.1.1 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 Pharma Mini flow cell 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.

Onsite Qualification Protocols and

Records: Installation Qualification