K-Patents PR-23 for K-Patents - Manual (Page 39)

Onsite Qualification Protocols and Records: Installation Qualification
7
© Copyright K-Patents 2011. All rights reserved.
39
7.5 Operating environment
Description of requirements
Ensuring that the environmental requirements for the system regarding temperature
are within specification. Ensuring that the appropriate power supply and power switch
are available.
Requirement acceptance values
Ambient temperature is between 20 and 30 °C (68 - 86°F). 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). An available water supply. Optional: Fume hood if required.
Failure to meet any off the acceptance values
A new environment must be established and the qualification performed again from
Section
7.3.1 (of this document) onwards.
Date Signature Pass
*
Conditional Pass Fail
*Conditional pass:
7.6 Installation
Requirement description
The authorized operator who in accordance with
Section 7.2 (of this document), must read
the start-up and operation instructions in Section 3 (of this document).
Requirement acceptance values
The relevant sections have been read.
Date Signature Pass
*
Conditional Pass Fail
*Conditional pass: