20 Years & Counting of CQV Services (Simple-Multiyear Capacity Plant Expansions)

About this Project

OBJECTIVE

Equipment Validation, Thermal Validation, Computerized System Validation, Laboratory Validation, Environmental Monitoring

SERVICES

We have performed projects ranging from simple projects lasting weeks to multi-year capacity expansions. We have had up to 30 consultants at the Los Angeles site at various times. PSC® has also performed CQV services for another site for almost as long PSC has worked with the Los Angeles, California site. Services have included equipment, laboratory, thermal validation, computerized systems validation, etc.

We have performed validation services for the start-up and optimization of many other sites. In Georgia, the work with our client began when the site was first under construction and continues to present day. We have performed evolving CQV services for three Massachusetts sites as our client there grew operations over the course of many years. PSC has performed a variety of CQV services, including environmental monitoring, for a Singapore site since 2010 from startup support through to expansion. We provide manufacturing support and technology transfer, secondment services include engineering project management, commissioning and qualification for new manufacturing equipment, computerized system validation, cleaning validation, SIP and equipment validation, materials qualification, microbiology laboratory chemist.

PROJECT SUCCESS

For these projects, PSC® provided/hired a Senior Validation, Commissioning, and Qualification Specialists who completed the projects in a timely manner and stayed within budget. Some of these projects are still ongoing projects. This company has been a client with us for over 20 years and continues to utilize our services.