Internal Audits
Meeting standards
An internal audit or review proving a gap analysis following identified internal standards or a subset of the regulations.
An internal audit or review following the expected parameters of a regulatory audit.
An internal audit or review proving a gap analysis following identified internal standards or a subset of the regulations.
- Focusing specific areas identified to be included
- Suggestions of how to address or mitigate issues
- Audit reports can provide recommendations for further action
An internal audit or review following the expected parameters of a regulatory audit.
- Focusing on areas expected from a regulatory audit
- Suggestions of how to address or mitigate issues
- Audit limited to review criteria, although other areas will be identified along with recommendations.
Supplier Audits
An organisation independent audit or review of a supplier to ensure that they are meeting quality and regulatory requirements for IT.- Focusing on general IT quality and repeatability.
- Ensuring that the appropriate regulations, PIC/S, GAMP, FDA predicate rules, CFR21 part 11, etc., are followed, where applicable
- Confirming that the Supplier is meeting and providing services to contracted levels.