13.7 Conclusion
QA activities are manifold and require a broad set
of skills and a dependable knowledge of GCP
regulations and clinical development processes.
Possible areas of occupation for QA auditors are
diverse: some are focusing on auditing and specia-
lize to become an expert in a specific area; others
would like to be flexible and conduct a variety of
audits. Moving into training and consulting is a
valid opportunity and even moving out of QA into
operational functions is possible. Most important,
though, for QA auditors is to skill to work with a
variety of functional areas and cross-functional, to
be detailed but also not to lose sight of the overall
picture. Auditors should be able to deal with con-
flicts and critical situations which may emerge in
auditing clinical trials and systems.
Regulatory authorities expecting QA programs
being established at sponsors and external service
providers. However, this should not be the only
reason for implementing a proper QA program at
the company. QA auditors can help ensure the
integrity and validity of clinical trial data from
the beginning to the end, from trial planning until
the final study report, through trial-related and
systems audits, training and consulting. While
QA’s contribution may not be easily measurable,
their investment in error prevention, compliance
assessments and contribution to inspection readi-
ness is a considerable benefit to the company and
adds value to the processes and procedures. Man-
agement support and adequate resources, however,
are mandatory to ensure that QA auditors and
programs are effective.
Last but not least, one should not forget that it is
not QA who is ultimately responsible for the
quality of the services and products, but it is
the individual involved in the clinical research
process.
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