Supplier Audit Management

Qualification, Audits, and Monitoring

We develop and manage supplier qualification programs, conduct second-party audits of your vendors, and help you build a risk-based supplier monitoring system. Our audits assess GMP compliance, quality agreements, and material specifications to protect your products and your reputation.

• Supplier qualification and approval programs
• Second-party vendor audits
• Risk-based monitoring systems
• Corrective action procedures for underperforming suppliers

When a Supplier Falls Short

Finding a problem is only half the job. We set up corrective action procedures for underperforming suppliers, help you decide when to remediate a relationship and when to replace it, and tighten your incoming material controls in the meantime. Supplier findings often surface during a GMP gap assessment, and the testing side of supplier trust runs through our testing compliance services.

Common Questions

What is a second-party audit?

An audit you commission of your own supplier, conducted on your behalf. We assess your vendor against GMP requirements, your quality agreement, and your material specifications, and report what we find so you can make sourcing decisions with real information.

How do we qualify a new supplier?

Through a documented qualification program: assessing compliance status, reviewing documentation, auditing where risk justifies it, and setting a quality agreement before the first purchase order.

How often should suppliers be re-evaluated?

It should be risk-based. High-risk materials and critical suppliers deserve closer, more frequent scrutiny than well-established low-risk vendors. We build monitoring systems that put your attention where the risk actually is.