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Quality Assurance
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VST provides a complete range of quality assurance (QA) services to pharmaceutical, biotechnology, and medical device companies. Whether you need to develop and implement quality systems from scratch, review and harmonize your existing systems, or obtain assistance with audit programs and other QA activities, our experienced, responsive team of quality professionals can help you any or every step of the way.

We pride ourselves on our pragmatic and flexible approach to quality management consultancy, auditing and training services. With service capabilities across all clinical development and production stages as well as ISO 9001;2000 expertise, we can provide strategic advice in identifying the quality management system you need to meet both your business and compliance needs. We can also develop the quality documentation for you and train your staff so that you have everything covered from the start.

Benefits

  • Global service capabilities covering all GxPs
  • Experienced team with expertise across all aspects of QA
  • Flexible and responsive service with tailored solutions to suit your needs

Services

  • QA consulting
  • Quality Management System planning and implementation
  • GMP, GCP, GLP and ISO audits
  • Post audit support (Corrective and Preventive Action (CAPA) plans, Project management, SOP writing and process improvement implementation)
  • Staff training (EU, US FDA, WHO and ICH regulations, audit and inspection preparation)
  • Computerized Systems Validation (CSV) planning, implementation and assessment (21 CFR Part 11 and Predicate Rule requirements Systems Development Life Cycle (SDLC) and Risk Assessment processes)