How Diligent meets regulatory requirements

Sponsors routinely outsource vendor qualification audits to qualified third-party auditors. ICH E6(R3) Section 3.6.6 permits sponsors to transfer trial-related activities—including auditing—to service providers, provided that qualified individuals perform the work (Section 3.4). Importantly, delegating an activity does not transfer the sponsor’s regulatory responsibility and accountability. This is a well-established industry practice.

That is what a Diligent audit report represents. Diligent Pharma assigns qualified, independent GxP auditors to conduct the same comprehensive qualification audit that your organization would otherwise conduct internally or commission from another qualified auditor. The deliverable is the same—a thorough, independent assessment of the vendor’s Quality Management System, SOPs, regulatory compliance posture, and operational capabilities. The only difference is that instead of each sponsor separately commissioning an auditor to produce the same assessment of the same vendor, Diligent’s auditor conducts the qualification audit once, independently, and the report is made available to any sponsor who needs it.

Regulatory agencies do not require you to physically step into a vendor’s facility or to generate the qualification data yourself. They require objective, verified proof that the vendor is fit for purpose (Section 3.6.10) —and they require that you, as the sponsor, actively evaluate that proof and document your qualification decision.