Points to Consider in Remote and Hybrid GMP/GDP Audits (single user digital version)

May 2022
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This Points to Consider document describes steps that can be taken to ensure an effective and efficient remote assessment. It introduces standard nomenclature to describe the types of remote audits and discusses key considerations for their scheduling, duration, planning, conduct, closing, reporting, and follow up. The document focuses on aspects of auditing that are different in the remote setting from those in on-site audits or that have a particular impact in the remote setting. This document is designed to assist both the auditor and auditee as they work through the challenges of remote and hybrid auditing and determine the changes in practices, standard operating procedures, and quality agreements that are necessary to facilitate effective and efficient remote audits.

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Table of Contents

Table of Contents:

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  1. [Introduction
  2. Glossary of Terms
  3. Determining Audit Type
  4. Scheduling a Remote or Hybrid Audit
  5. Planning a Remote or Hybrid Audit
  6. Conducting a Remote or Hybrid Audit
  7. Wrap-up and Closing of a Remote or Hybrid Audit
  8. Reporting in a Remote or Hybrid Audit
  9. Follow-up to a Remote or Hybrid Audit
  10. References

Figures and Tables Index]