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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