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The FDA in early 1998 proposed
and ultimately adopted a new process for performing quality system inspections
at medical device manufacturing facilities. The new method is called Quality
System Inspection Technique (QSIT.) QSIT uses a "top down" approach
making the management of the quality system the central theme of of facility
inspections. The intent is to help investigators to concentrate on
manufacturing and quality areas, increase compliance to the quality system
regulation, and move the FDA inspection techniques in line with Global
harmonization efforts.
The QSIT approach assumes that there are seven
sub-systems in the quality system regulation (21 CFR, Part 820). Four are
considered primary areas and these four; Management Controls, Design Controls,
Corrective and Preventive Actions (CAPA) and Production and Process Controls
are the main focus during an inspection. The remaining three subsystems;
Material Controls, Records, Documents, and Changes, Equipment and Facilities
are covered as links associated with the four primary subsystems.
The FDA in early 1998 proposed and ultimately adopted a
new process for performing quality system inspections at medical device
manufacturing facilities. The new method is called Quality System Inspection
Technique (QSIT.) QSIT uses a "top down" approach making the
management of the quality system the central theme of of facility inspections.
The intent is to help investigators to concentrate on
manufacturing and quality areas, increase compliance to the quality system
regulation, and move the FDA inspection techniques in line with Global
harmonization efforts.
The
QSIT approach assumes that there are seven sub-systems in the quality system
regulation (21 CFR, Part 820). Four are considered primary areas and these
four; Management Controls, Design Controls, Corrective and Preventive Actions
(CAPA) and Production and Process Controls are the main focus during an
inspection. The remaining three subsystems; Material Controls, Records,
Documents, and Changes, Equipment and Facilities are covered as links
associated with the four primary subsystems
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This chart, compiled after the
introduction of QSIT from a sampling of "483" observations, shows the
percentage of problems reported for each of the four major quality system
subsystems
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Establishing an effective and
appropriate quality system and
managing regulatory compliance is often complex, constantly changing, and
demands diligence and training to assure that all company operations are
performed within regulatory requirements. It can be a daunting and often
stressful task that can become overwhelming.
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If you
are setting up a regulatory compliance program or improving your existing
system, we can help. At R. M. Baldwin, Inc. we provide cost effective
regulatory compliance programs, tools, and training that can save time and
money.
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