5 system qualification, 6 setting up the system components and devices – K-Patents PR-23 for K-Patents User Manual

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Onsite Qualification Protocols and Records: Operational Qualification

8.5 System qualification

Check that the system is the same as defined in the IQ, with no changes.

Definition of requirements
All system equipments remain the same as for the IQ and ancillary equipment IQ is valid.

Date

Signature

Pass

Conditional Pass

Fail

Conditional pass:

8.6 Setting up the system components and devices

Description of requirements
The Pharma Refractometer system comprised of Refractometer sensor, Laboratory Test
Cuvette LTC and Indicating transmitter, is assembled and mounted correctly as described
in the

Section 3 (this document). Initial startup cheks for the Refractometer have been

made according to PROCESS REFRACTOMETER PR-23 INSTRUCTION MANUAL,
Section 5. Also the ancillary thermostatic bath and the sample delivery system (if required)
are connected in accordance with the

Section 3 (this document). The ancillary equipment

is switched on and functional cheks are made in accordance with the corresponding
operating manuals.

Requirement acceptance values
The system and devices are complete and have been set up in compliance with
the instructions.

Failure to meet any of the acceptance values
Terminate the OQ.