Chemistry Reference
In-Depth Information
tAble 2.1
timing, Applicability, and Activities for each phase of AIQ
dQ
IQ
oQ
pQ
timing and Applicability
Prior to purchase of a
new instrument
At installation of each
instrument (new, old, or
existing unqualified)
After installation or
major repair of each
instrument
Periodically at specified
intervals for each
instrument
Activities
Assurance of
vendor's DQ
System description**
Fixed parameters**
Preventive maintenance
and repairs
Assurance of
adequate support
from manufacturer
Instrument delivery
SOPs for operation,
calibration,
maintenance, and
change control
Instrument's fitness
for use in lab
Utilities/facility/
environment
Network data and
storage**
Secure data storage,
backup, and
archive**
Assembly and
installation
Installation verification**
Instrument function
tests**
Performance tests**
Note:
Activities under each phase are usually performed as given in the table. However, in some cases, it
may be more appropriate to perform or combine a given activity with another phase. Activities
spanning more than one phase are indicated by the double asterisk.
service, and training. Vendor-supplied documentation and consumer audits of the
vendor are usually sufficient to satisfy users' DQ requirements.
2.3.2 I
nStAllAtIon
Q
uAlIfIcAtIon
(IQ)
During the IQ phase in Figure 2.1, all the activities associated with properly install-
ing the instrument (new, preowned, or existing) at the users' site are documented.
A system description, including manufacturer, model, serial number, etc.; proper
site requirements; and the receipt of all the parts, pieces, manuals, etc., necessary
to perform the installation are confirmed. Table 2.2 illustrates an example of a form
that might be used during IQ to document instrument components. During physical
installation, all of the fluidic, electrical, and communication connections are made
for components in the system. Documentation describing the instrument and compo-
nents (e.g., Table 2.2), how the instrument was installed, who performed the instal-
lation, and other miscellaneous details should be recorded, signed off, and archived.
An installation verification confirming the success of the installation should also be
performed before proceeding to the next phase.
