Quality Assurance Consulting
VTI Life Sciences offers expert national and international quality assurance consulting to help FDA-regulated companies build and maintain the quality systems that keep them inspection-ready. Our QA consultants bring years of individual and collective experience across FDA-regulated industries, with the expertise and insight to make qualified recommendations you can trust.
We connect with the leading regulatory and industry experts to keep us abreast of developments that might affect your company. Additionally, we regularly participate in industry associations such as RAPS, ISPE and ASQ.
We have experience in these areas:
- Written Quality Assurance Policies and Manual
- Establishing CAPA, Deviation, Vendor Auditing and Quality Systems Programs
- Developing Quality Risk Assessment/Management Systems
- Perform Mock Audits
- Validation Assessments
- GAP Analysis
- Developing Document Control Systems
- Third Party Audits by our Certified Lead Auditors
What is quality assurance in an FDA-regulated environment?
Quality assurance is the system of policies, procedures, and controls that ensures products are consistently produced and controlled to quality standards. In a regulated environment it’s what keeps a company inspection-ready and is where FDA investigators focus first.
What is a CAPA system?
CAPA stands for Corrective and Preventive Action — a formal system for investigating problems, fixing their root cause, and preventing recurrence. A functioning CAPA system is a core FDA expectation and one of the most common areas cited in 483 observations.
What is a mock audit and why do I need one?
A mock audit is a simulated regulatory inspection that finds and closes compliance gaps before a real FDA investigator does. VTI performs mock audits and inspection-readiness assessments so weaknesses surface on your timeline, not the agency’s.
What is a gap analysis?
A gap analysis compares your current quality systems against regulatory requirements and identifies where you fall short. It’s the starting point for a targeted remediation plan rather than guesswork.
What quality systems can VTI help build?
VTI helps develop QA policies and manuals, CAPA and deviation systems, vendor auditing programs, quality risk management systems, document control systems, and third-party audits by certified lead auditors.
