19 Research Drive, Amherst, Massachusetts 01002 USA
(413) 253-0077
(413) 253-0811

Quality System Audits

Growing strong customer partnerships is a cornerstone of VTS Consultants’ mission. By working closely with our clients to develop focused approaches, we solve complex challenges while exceeding standards for quality. In a climate of evolving and expanding regulatory demands, let the VTS team forge solutions for you.

Quality System Audits

One of the fastest growing areas of need today lies in meeting quality system regulations for the performance of internal audits and audits of critical vendors and suppliers.

With an increasing number of companies contracting out manufacturing and filling processes, and the emerging dependence on suppliers for everything from raw materials to services, VTS Consultants is routinely called upon to help meet these requirements.

These audits help to identify internal cGMP deficiencies while assuring that vendors have quality programs designed to deliver the products or services required.

VTS Consultants not only summarizes deficiencies found during quality audits performed, we also provide the client with recommended corrective actions to implement for their resolution.

In addition to auditing services, VTS Consultants can assist clients with regulatory submission documents and pre-approval inspections.

Our quality group, which includes former FDA inspectors, can help provide responses to address regulatory observations or warning letter issues.