VTI Life Sciences provides independent auditing services that help FDA-regulated companies find and close compliance gaps before an inspector does. Our certified lead auditors bring extensive experience across pharmaceutical, biotechnology, biological, medical device, and related industries — auditing quality systems against FDA regulations and international standards including 21 CFR 820, ISO 13485, and ISO 9001.
Whether you need an independent set of eyes on your quality system, a readiness check before an FDA inspection, or a supplier evaluated before you sign, VTI's auditors deliver practical, value-added findings — not just a list of problems, but clear recommendations you can act on.
Our Auditing Services
- Internal Audits — independent evaluation of your quality system to surface compliance gaps, risks, and improvement opportunities
- Mock FDA Inspections — a simulated inspection that finds weaknesses on your timeline, not the agency's
- Supplier & Third-Party Audits — evaluate vendors and contract partners against your quality requirements before and during engagement
- Gap Assessments — measure your current systems against 21 CFR 820, ISO 13485, or ISO 9001 and identify exactly where you fall short
- Certification Readiness Audits — confirm you're prepared before a certification or registrar audit
A Partner Beyond the Audit
VTI's role doesn't end when the audit report is delivered. Our auditors work alongside your team to help interpret findings, prioritize corrective actions, and build the internal competence to keep your quality system strong. With 25+ years supporting FDA-regulated manufacturers worldwide, VTI helps you turn audit findings into lasting improvement.
FAQ
What is the difference between an audit and an inspection?
An audit is typically a planned, independent evaluation you arrange to check your quality system against a standard or regulation. An FDA inspection is conducted by the agency itself. A mock audit lets you experience an inspection-style review on your own terms, so problems surface before the FDA arrives.
What is a mock FDA audit?
A mock FDA audit is a simulated inspection that replicates how an FDA investigator would review your facility and quality system. It identifies gaps and weaknesses ahead of a real inspection, giving you time to correct them rather than responding to a Form 483 after the fact.
What is an internal audit and why is it required?
An internal audit is an independent review of your own quality system to confirm it's working and compliant. FDA regulations and standards like ISO 13485 require organizations to conduct internal audits, and a well-run program is one of the clearest signals to an inspector that your quality system is under control.
What standards can VTI audit against?
VTI's certified lead auditors audit against FDA regulations and international standards including 21 CFR 820, ISO 13485, and ISO 9001, tailored to your industry and quality system.
What is a supplier audit?
A supplier audit evaluates a vendor or contract partner against your quality requirements before or during an engagement. It reduces the risk of a supplier's problems becoming your compliance findings, which is especially important in FDA-regulated supply chains.
What happens after the audit?
VTI delivers clear, prioritized findings with practical recommendations — not just a list of problems. Our auditors help you interpret the results, plan corrective actions, and strengthen your quality system so the improvements last.
