5 operating environment, 6 installation, 5 operating environment 6.6 installation – K-Patents PR-23 for K-Patents Appendix User Manual
Page 37

Onsite Qualification Protocols and Records: Installation Qualification
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6.5 Operating environment
Description of requirements
Ensuring that the appropriate power supply and power switch are available.
Requirement acceptance values
An electrical power supply with a voltage and frequency of 100-230 VAC/50-60 Hz (Optional
24 VDC). A computer (PC, Mac, PDA or mainframe).
Failure to meet any of the acceptance values
A new environment must be established and the qualification performed again from
6.3.1 (of this document) onwards.
Date
Signature
Pass
*
Conditional Pass
Fail
*Conditional pass:
6.6 Installation
Requirement description
The authorized operator who in accordance with
Section 6.2 (of this document), must read
the installation instructions in
Section 3 (of this document).
Requirement acceptance values
The relevant sections have been read.
Date
Signature
Pass
*
Conditional Pass
Fail
*Conditional pass: