K-Patents PR-23 for K-Patents Appendix - Manual (Page 34)

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 2013
34
Appendix to the Instructions Manual PR-23
6.1.2 Authorized officiator
Selection of the individual authorized to carry out the Installation Qualification of the Pharma
Refractometer system should be in accordance to their relevant ability to undertake the
procedure. The authorized officiator’s signature is required for the next stage to validate
Date/Initials in the Installation Qualification log and reports.
Name:
Function:
Date:
Signature:
Initials:
6.1.3 Execution
As it is executed, each described step of the Installation Qualification requires initialing
and dating. If any deviations occur, the qualification must either be aborted or a detailed
explanation of the deviations must be entered in the subsequent “Deviation, evaluation,
corrective actions” logs and must be documented appropriately.
6.2 System
6.2.1 Qualifying the system
Location of the Pharma Refractometer Sensor and Pharma Mini flow cell:
Location of the Indicating Transmitter:
Device Serial Number Supplier Manufacturer
Pharma Refractometer:
Sensor PR-23-AC-62-HSS
K-Patents Oy
Pharma Refractometer: Indicating
transmitter DTR-M/U-GP-SC
K-Patents Oy
Computer