Owner's manual

4 Appendix
797 VA Computrace / Hardware-Manual 8.797.8001EN
112
4.4 Validation / GLP
GLP (Good Laboratory Practice) requires, among other things, that the precision and
correctness of analytical instruments is checked at regular intervals by using SOPs
(Standard Operating Procedures, SOP).
In the 797 VA Computrace
Software, a GLP Wizard is integrated. If this function is ac-
tivated, the GLP Wizard monitors your system, reminds you of due verifications, leads
you through verifications and creates your GLP-report.
An example of such a standard operating procedure is available from Metrohm under
the title «Application Bulletin No. 276 – Validation of Metrohm VA instruments
using Standard Operating Procedures(SOP)». This SOP can be adapted for your
VA system and used for its validation.
The 797 VA Computrace Stand must be included as a part of the whole voltammetry
system, whose most important components include control- and evaluation software,
PC, possible Sample changer and Dosing devices, in the all-embracing validation of
the whole system.
Please contact your local Metrohm agency in order to receive support in validating
your 797 VA Computrace Stand. It can also provide you with validation documentati-
on which will help you to carry out your installation qualification (IQ) and operational
qualification (OQ).
Further information about QA, GLP and validation can also be found in the brochure
«Quality management with Metrohm» which is also obtainable from your local
Metrohm agency.
Checking the electronic and mechanical assemblies of Metrohm instruments can and
should be undertaken within the framework of regular servicing by Metrohm tech-
nicians. All Metrohm instruments are equipped with start-up check routines, which
check that the relevant assemblies are functioning perfectly when the instrument is
switched on. If no error message appears it can be assumed that the instrument is
functioning properly.
The 797 VA Computrace Stand also contains a built-in diagnosis program which al-
lows the service technicians to check the functioning of particular assemblies should
faults or malfunctions occur and to localize them.