R22019

Risk Assessment Matrix Index:0

-Internal audit programme- Date:06/06/2022

Justification for Action Priority (AP): Increased audits frequency in case of Hight risk

Risk Assessment :
*Predefined quality limits should be established to identify systematic issues that can impact subject safety or data integrity.

*Detection of deviations from the predefined quality limits should signal a need for further action.

SCORE HIGH MEDIUM LOW

Endpoint selection 6 4 2

Never Audited or Every 3 years

significant or less than 3
Audit history change :6 Over 3 years: 4 years:1

Corrective/ Corrective/
Preventive Corrective/ Preventive
Actions not Preventive Actions closed
properly Actions in agreed
Compliance followed:4 delayed: 2 timescale: 1

Methodology risk
score Validation is Validation is Validationis
Validation of incomplete and incomplete or complete and
method/ methodology is methodology is methodology is
Established under under well
methodology development :6 development: 4 established: 1
r data integrity.