Frequently Asked Questions
Answering some of the most common questions about Diligent, our platform, and our model.
Sponsor Questions
Why is using a Diligent audit report a compliant way to qualify a vendor?
ICH E6(R3) requires sponsors to assess service provider suitability and maintain access to relevant information, such as SOPs and performance data, for selection and oversight. It permits sponsors to outsource trial-related activities, including auditing, which is common industry practice. Diligent provides the audit data; the qualification decision itself always remains with the sponsor. To use a report compliantly, sponsors should: (1) confirm Diligent and its auditors are qualified and experienced, (2) document that they reviewed the report and that its scope covers the intended use of the vendor, and (3) document that they reached their own qualification decision based on that review. In short: outsourcing vendor auditing has always been an industry-approved practice, and Diligent is simply a faster way to do it.
How experienced are Diligent's auditors?
Our auditors have a minimum of 10 years of relevant GxP auditing experience and complete annual regulatory training to stay current with industry best practices and regulations.
Where can Diligent conduct vendor audits?
Our auditors have a minimum of 10 years of relevant GxP auditing experience and complete annual regulatory training to stay current with industry best practices and regulations.
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