Metrohm 817 Bioscan - Manual (Page 72)

5 Notes – Maintenance – Faults
817 Bioscan
64
5.5 Validation / GLP
The requirements of GLP (Good Laboratory Practice) include a peri-
odic check of analytical measuring instruments with regard to their re-
producibility and accuracy using Standard Operating Procedures,
SOP.
Further information on the subjects of QA, GLP and validation can also
be found in the brochure
«Quality management with Metrohm»,
which is available from your local Metrohm agency.
The 817 Bioscan as part of a complete IC system, whose most impor-
tant components also include separating column, pump and evaluation
system, must be incorporated in its comprehensive validation.
Testing of the electronic and mechanical function groups of Metrohm
instruments can and should be performed as part of a regular service
by trained personnel of the manufacturing company (see section 5.2.1).
All Metrohm instruments are equipped with start-up-test routines that
check for perfect functioning of the relevant assemblies when the in-
strument is switched on.
The Metrohm company also supplies its instruments with an integrated
diagnostic feature (see section 5.4) which, in the case of possible mal-
functions or faulty behavior, allows the user to check the functioning of
certain assemblies and localize the fault. Diagnostic programs can also
be integrated in a validation procedure.