As an integrated part of any quality assurance program an audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

Wahoo Clinical follows ISO19011 and applies the standard principles of auditing: integrity, fair presentation, due professional care, confidentiality, independence and evidence-based approach.

Services include:

Wahoo Clinical provides the following routine and for-cause audit activities:

• Independent GCP audits
• Investigational site / facility audit
• Third party vendors audits
• Clinical study audit: in-life (in-process)
• Clinical study audit: after completion (pre-approval, inspection readiness)
• Process or system audits

In an initial consultation we will discuss with the client:

• Objectives - what is to be accomplished by the audit
• Criteria - against which the audit will be conducted (e.g. sponsor SOPs, protocol, GCP, cGMP, 21 CRF Part 11, applicable regulatory requirements and more)
• Scope - extend and boundaries of the audit
• Reporting strategy

Other supportive services:

• Inspection readiness training
• Pre-inspection support and preparedness