GxP Audit and Inspection Readiness Checklist Form
Use this checklist to review audit and inspection readiness, identify gaps, and record follow-up actions before the visit.
Audit Scope and Site Details
Site or Facility Name
*
Department or Area Under Review
*
GxP Domain
*
GMP
GLP
GCP
GDP
Other
Audit or Inspection Type
*
Internal Audit
Customer Audit
Regulatory Inspection
Mock Inspection
Other
Planned Audit or Inspection Date
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Name or Role of Person Completing the Checklist
*
Readiness Checklist
Readiness Checklist
*
Rows
Status
Notes
Documented procedures/SOPs current and accessible
1
Training records complete and current
2
Records/logbooks complete and traceable
3
Equipment qualification/calibration/maintenance current
4
Facilities/housekeeping and environmental controls adequate
5
Deviations/CAPA open items tracked and controlled
6
Data integrity controls in place
7
Previous audit findings closed or addressed
8
Documented procedures / SOPs notes
Training records notes
Records / logbooks notes
Equipment qualification / calibration / maintenance notes
Facilities / housekeeping / environmental controls notes
Deviations / CAPA notes
Data integrity and previous findings notes
Overall Assessment and Follow-Up
Overall readiness rating
*
Not Ready
1
2
3
4
5
6
7
8
9
Fully Ready
10
1 is Not Ready, 10 is Fully Ready
Top three gaps or corrective actions needed
*
Expected date to complete remediation
*
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Prepared to proceed with the audit/inspection?
*
Yes
Yes with minor gaps
No
Submit Checklist
Should be Empty: