POINTS TO CONSIDER FOR COMMISSIONING AND QUALIFICATION OF MANUFACTURING FACILITIES AND EQUIPMENT - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 167

Qualification efforts, including software validation, verification, and testing
should be based on the level of confidence in the system as well as the use
of the system and complexity (FDA guidance). Consider the effect of software
modifications on product quality. Modifications to critical function modules may
be controlled, but modifications to noncritical functions or applications may not
be—although they may indirectly have an effect on product quality. Computer
system functions or software requiring additional efforts may include systems
that:
• control, monitor, record operations that can adversely affect product quality
or patient safety;
• collect, manipulate, or report data used to make decisions that may have an
adverse affect on product quality or patient safety;
• are relatively new or for which the company does not have previous expe-
rience; and
• affect complex operation that could have an adverse affect on product quality
or patient.
Other computer system qualification points to consider are as follows:
• Risk to product quality may include interaction with nonvalidated systems,
including Internet access.
• Systems should provide access security and audit trail for changes.
• Automated control systems should be qualified before the qualification of
the mechanical systems they control, monitor, or operate.
• Companies may use information from automated monitoring systems to
show that operating or environmental systems are operating properly if those
automated systems have been qualified.
• Be cautious of changes made by the vendor after FAT or other commission-
ing testing.
• Be cautious of damage to electronic circuitry during shipment and storage
post-FAT or commissioning testing.
7.3.18 Requalification
Qualified systems should be maintained in their qualified state. A program for
doing so should include the following:
• preventive maintenance;
• calibration;
• evaluation of system performance;
• change control;
• investigation of process performance; and
• quality audit.