Chemistry Reference
In-Depth Information
Each laboratory should have SOPs in place that define the period of use (usually
defined as a reasonable interval during which the instrument operates without any
loss in functional performance) and the procedures for placing the instrument on-
line following maintenance (OQ, PQ, or system suitability), as well as for proper
maintenance and calibration.
2.4 roles And responsIbIlItIes
Although consultants, validation specialists, and quality assurance (QA) personnel
will often be involved in the AIQ process, the users are the ones who ultimately
“own” the process of AIQ, and are responsible for maintaining the instrument in a
qualified state. QA personnel have the responsibility to review the AIQ process to
determine that it meets regulatory requirements and to ensure the scientific valid-
ity of the process. Manufacturers and developers are responsible for the DQ and
for relevant processes used in the manufacturing and assembly of the hardware and
software associated with the instrument. Vendors usually make available a summary
of these efforts, as well as a test script that can be used to qualify the instrument and
software at the user's site. Manufacturers should also notify users about hardware or
software defects, offer training, service, and repair.
2.5 soFtWAre vAlIdAtIon And cHAnge control
Just about every piece of hardware used in the modern laboratory today is software
driven or controlled. Whether it is firmware (integrated chips), software used for
instrument control, data acquisition and processing (e.g., chromatography data sys-
tems or CDS), or stand-alone software, such as laboratory information management
systems (LIMS), it all must be validated.
Firmware is validated by the manufacturer during DQ; and because it is gener-
ally considered part of the instrument itself, when the hardware is qualified, the
integrated firmware is also qualified. The same can be said for the CDS; rather than
performing a modular validation of the software by itself, the CDS is qualified by the
user by qualifying the instrument according to the AIQ process in place.
Change control also follows the DQ/IQ/OQ/PQ process as manufacturers add
new features and correct known defects in their instrumentation. The change control
process enables the user to determine what (if any) changes should be adopted, and
to assess the effects of changes to determine what (if any) requalification is required.
Software reloads or upgrades are considered major repairs, and requalification is
necessary. An IQ should be performed whenever loading new software, reloading
software (e.g., after a hard disk drive failure), adding service packs, or upgrading to
new versions. An OQ should then be performed to verify computational capability.
2.6 AIQ documentAtIon
Two types of documents result from AIQ: static and dynamic. Static documents are
generated during the DQ, IQ, and OQ phases and should be kept accessible, either
electronically or in a separate qualification binder. Static documents may include
