TABLE I

Installation Qualification Test Results

ProcedureExpected ResultsResults As Expected (Yes/No)
System documentation verificationAll manuals and implementation guide associated with the equipment were reviewed and found to be accurate. Location of documentation is documented in the protocol.Yes
Equipment/component listAll equipment/components were verified and documented in the protocol. The fax modem-1 was replaced with a new modem with all details documented in the protocol.Yes
Instrument calibration verificationAll the instruments were listed. The critical instruments were calibrated and NIST-traceable. A re-calibration interval for critical instruments has been established. The thermometer was replaced with a new one and details were documented in the protocol.Yes
Utility verificationAll the utilities required for the system were connected according to the requirements. The source and actual voltage were recorded. The instrument (multimeter) used to measure actual voltage was calibrated and NIST-traceable.Yes
Installation verificationThe components are correctly installed according to the procedures listed.Yes
Software verificationAll the software including the name and version of the software were verified. All the software CDs are safely located in the server room.Yes
Installation environmental condition verificationThe installation location was verified and the temperature and humidity of the room was measured with a calibrated humidity and temperature probe. The probe used to measure temperature and humidity was calibrated and NIST-traceable. The environmental conditions meet the manufacturer's requirements and our acceptance criteria.Yes