Audits
Our audits 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.
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