Set the Stage (Logistics, Schedule Staff)
Recommendations for preparation for the actual audit include:
- For on-site audits: Lodging and transportation (including airport(s), recommendations for the auditor(s), auditing room reservations, plans for provision of refreshments and lunch (if providing lunch ask auditors for dietary restrictions), parking instructions, and building access instructions.
It is important to give auditor(s) ample room for their laptop, notes, and documents/records being examined. If there are more than one auditor and they are auditing different topics, they may each require a separate room in order to discuss and conduct interviews.
- For remote audits: Upload requested documents to a secure, shared site that the auditor(s) can access. Many auditors will ask for an Organization Chart, Table of Contents of procedures, list of software application used in fulfillment of REMS obligations, objective evidence from previous audit observations where the auditor needs to verify completion of the corrective action, relevant MSA, addenda, and SOWs, and other information prior to the start of the audit.
Alert lead staff as to when their participation in the audit may be needed.
