Observant, that is actively aware of physical sur-
roundings and activities.
Perceptive, that is instinctively aware of and able to
understand situations.
Versatile, that is adjusts readily to different situa-
tions.
Tenacious, that is persistent, focused on achieving
objectives.
Decisive, that is reaches timely conclusions based
on logical reasoning and analysis.
Self-reliant, that is acts and functions indepen-
dently while interacting effectively with
others.
The standard also outlines the the following
areas in which QA auditors should be competent:
1.Audit principles, procedures and techniques:
This includes knowledge on the ethical and
professional conduct of audits, interaction
with auditees and co-auditors, confidentiality,
fair presentation of results and observations in
an audit report and the need to be objective
throughout the audit process and to base con-
clusions only on audit evidence.
2.Management system and reference documents:
This comprises the SOPs, working instruc-
tions and other internal documents to demon-
strate that the company’s processes and
procedures comply with GCP and regulatory
requirements.
3.Organizational situations: Organizational charts,
internal reporting lines and relationships with
external service providers and partners fall into
this category.
4.Applicable laws, regulations and other require-
ments relevant to the discipline: The QA auditor
should be aware of international GCP regula-
tions, regulatory requirements in the relevant
countries where clinical trials are conducted as
well as any protocol requirements and trial-
related procedures and contracts.5.Quality-related methods and techniques:
Knowledge of methods applied in quality man-
agement, for example use of checklists and
forms to record audit observations, sampling
techniques, interview techniques, verification
of information and writing audit reports must
be acquired by the auditor. Communication
skills, both oral and written, are essential for
QA auditors to ensure adequate communication
with auditees and management.6.Processes and products, including services:QA
auditors must possess a good understanding of
all processes in clinical research and drug devel-
opment and be familiar with the terminology
and abbreviations used related to clinical trials.Training of QA auditors
Induction training in QA may comprise the general
audit procedures employed at the company, key
audit SOPs and documentation requirements in
QA. A thorough review of the regulatory frame-
work for GCP is recommended, as QA auditors are
expected to be experts for clinical trial regulations
and all GCP aspects. It would impair the QA
auditors’ credibility if they knew less than the
auditees of the requirements that must be adhered
to in drug development.
Auditing cannot be learned in a theoretical
course and on-the-job training is mandatory. It is
recommended that the QA auditor be accompanied
during the first audits to learn from an experienced
and competent auditor and to qualify for conduct-
ing audits alone (Hattemer-Apostel, 2000b).
With the changing regulatory environment and
evolving internal company processes, continual
training is also required in QA. Attending internal
and external trainings and seminars, meeting QA
peers to exchange experiences and discuss audit
situations and interpretation of regulations refines
the QA auditor’s knowledge (Hattemer-Apostel,
2001). It goes without saying that QA auditors,
like everyone in clinical research, should maintain
a training file to document their qualification.13.3 IMPLEMENTING QUALITY ASSURANCE 163