Followup Audit Findings

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Overview of the procedure for follow up of
site audit findings.

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Followup Audit Findings

  1. 1. FOLLOW UP OF AUDIT FINDINGS SOP Number: Effective Date : Version Number & Date: Review Date: Superseded Version Number & Date : PURPOSE This SOP describes an overview of the procedure for follow up of site audit findings. RESPONSIBILITY This SOP is applicable to Internal Quality Assurance Auditors of XXXXXX conducting internal audits. PROCEDURE Once the audit has been completed the XXXXXX auditor will prepare a draft audit report, and review of the report will be completed within XX working days. The auditor will ensure that corrective actions are prepared, implemented by the CRC within the specified timelines. All corrective actions, including minutes of post audit meetings and revised documents, will be filed in the audit file. If the follow up action is required, the site CRC or appropriate designee, will prepare a corrective action plan Once all issues have been resolved, all copies of the report will be recalled and the report, along with supporting documentation, filed in secure storage. An audit log (appendix A) will be maintained listing studies and sites audited dates of audits, and the identities of the auditors. CONFIDENTIAL – STRICTLY FOR REFERENCE USE ONLY Page 1 of 2
  2. 2. FOLLOW UP OF AUDIT FINDINGS SOP Number: Effective Date : Version Number & Date: Review Date: Superseded Version Number & Date : CONTACTS 1. Quality Assurance Designate 2. Regional Head of Quality Assurance 3. Director of Quality Assurance LINKS None APPENDIX Appendix A: Audit log FOR FURTHER DETAILS CONTACT: clinswift@gmail.com CONFIDENTIAL – STRICTLY FOR REFERENCE USE ONLY Page 2 of 2

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