Weinel IT Service Logo

Regulatory IT - Auditing and Review

Internal Audits

Meeting standards
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
Regulatory readiness
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.