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

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Superseded Version Number & Date :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. 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Superseded Version Number & Date :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