Quality Audits

As a result of an increasing number of companies contracting out manufacturing and filling processes, VTS Consultants is often called upon to perform quality and system vendor audits. These audits help to identify internal cGMP deficiencies along with assuring that vendors have quality programs designed to deliver the products or services required. VTS Consultants have performed these audits on computer software development companies, biotechnology processes, high purity water system designs, and quality control laboratories. VTS Consultants will not only summarize deficiencies found during quality audits performed, but we also provide the client with the 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 some former FDA inspectors, can help provide responses needed to address regulatory observations or warning letter issues.