Computer Systems Validation Services

Customized Solutions for Automated Systems, at Any Stage of Their Lifecycle

At ProPharma Group, computer systems validation (CSV) is thought of as a lifecycle program that dictates how pharmaceutical, biotechnology, and medical device automation systems are to be addressed from conception through implementation, use, and finally retirement. We view CSV as an important spoke in the overall wheel of compliance, and we bring a broad range of support services with proven success in balancing business process understanding and best-fitting current compliance practices.

Depending on your specific needs, ProPharma Group designs project teams with specific skill-sets to provide an adaptable service. The result? You benefit from the least burdensome, yet most cost-effective and successful validation approach. We apply best practices to the configuration, design, and implementation of quality management systems (e.g., change control, CAPA, document control, Delta V BAS, and LIMS), as well as to the additional systems used in the manufacturing of the product. Furthermore, we deliver the system controls needed to meet the FDA guidelines for laboratory equipment. ProPharma Group can easily deploy the right individual or team to execute the tasks needed to augment your needs.

With an extensive understanding of key regulated business processes, our experienced staff can provide expert support for all aspects of project planning and oversight, including:
  • Risk assessments
  • Validation master planning (VMP)

With a full understanding of the system lifecycle, complemented by our experience in business processes, ProPharma Group can offer CSV support across a very diverse system portfolio, including:
  • Building, facility, utility control systems
  • Manufacturing process control systems
  • IT infrastructure
  • Manufacturing execution systems
  • Laboratory data acquisition and information systems
  • Quality workflow and document management systems
  • Clinical trial and data management systems
  • Medical information systems
  • Enterprise resource planning