Audit My Suppliers
What You Are Dealing With
You are responsible for the compliance of your supply chain and you do not have the internal resources or bandwidth to audit every critical supplier on the schedule they require. Regulatory authorities expect you to have a defined, documented program for qualifying and overseeing your external partners, and an audit that was performed years ago does not satisfy that expectation. When a supplier has a quality problem it affects your product, your timeline, and potentially your regulatory standing. You need an independent, experienced team that can conduct audits to a credible standard and give you findings you can act on.
How We Approach It
We design and execute supplier and contract partner audit programs tailored to your supply chain and regulatory requirements. We conduct onsite cGMP and quality audits, develop comprehensive findings reports, track CAPA commitments from vendors, and make sure your audit program produces the documented oversight the FDA expects to see. We work under your existing procedures or help you build a program from the ground up.
What We Have Done
A virtual pharmaceutical company that outsources all manufacturing, packaging, and testing engaged MEDVACON to conduct cGMP and quality audits across their API manufacturer, contract laboratory, and API storage warehouse across three states. MEDVACON executed all audits under the client’s procedures and delivered comprehensive findings across every site.
A pharmaceutical company engaged MEDVACON to audit their TrackWise quality documentation management system hosting provider, which had not been audited in several years. MEDVACON conducted CSV and GMP audits across two locations, reported critical observations to client leadership, and managed CAPA follow-up through to vendor certificate issuance.