provide clients with a comprehensive examination of their computerized
and non-computerized systems for compliance with established standards
for good practices as well as the laws and regulations administered by
FDA. The scope of the audit will include the documentation and
performance of activities that have a bearing on the quality and operational
performance of the audited systems. During audits, EduQuest
can assume responsibility for directing the overall audit but we will
always: (1) inform the client of plans and schedules related to the
audit; (2) provide the client with key observations and information which
may have an impact on the schedule of the audit; and (3) provide
continuous feedback to client personnel throughout the audit.
Additionally, we encourage all clients to use our audits as training
exercises with the goal of teaching client personnel how to conduct
similar internal assessments in the future.
At the conclusion of an audit,
we provide a written prioritized list of all significant observations and
discuss each of them with the client during a scheduled closeout
meeting. This closeout discussion addresses each observation, its
significance, and its status relative to the laws and regulations
administered and enforced by FDA. EduQuest also provides the client with
recommendations for follow-up as needed, in such areas as validation,
training, and creation or revision of written procedures.