Scope; Instructions - Elitech FreezePoint 6000 Series User Manual

Installation, Operation, and Performance Qualification

Scope

This protocol defines the methods and documentation to be used for evaluating the instrument according
to the manufacturer's specifications and intended use. Successful completion of this protocol will verify that
the instrumentation operates in accordance with intended usage.
Installation checks will be performed to verify that the Instrumentation has been installed in a proper
environmental setting, with proper connections, utilities, and reagents.
Instrument calibration will be verified.
The instrument system will be tested for proper operation of mechanical systems, menu functionality and
result reporting (display, serial output, and printer).
Performance claims will be verified (precision (within run repeatability), accuracy (linearity) and stability).
Certification of Conformance will be included.
Functional testing of instrumentation (where appropriate) will be performed to ensure system integrity.
Trained and well informed personnel will perform qualification studies.
Any exceptional conditions encountered during the qualification studies will be identified for review.
Exceptional conditions will be investigated and the appropriate course of action determined. All data will be
documented.

Instructions

This document is to be completed at the time the instrument is unpacked and set up for operation.
The individual in charge at the end user's location should check the instrument system and perform the
various tests as outlined in this Installation, Operation, and Performance Qualification section. Each result
will be noted and dated in this section.
All deviations from normal specifications, including any problems with installation, should be noted under
COMMENTS. All solutions to such problems will also be noted in the COMMENTS section.
This document contains proprietary information and is not to be duplicated in any way without the
expressed written consent of ELITechGroup.
113