QA CSV | System Implementation & Upgrading
- Area: Greater St. Louis Area
- Project Type: CSV
About this Project
Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation.
PSC Biotech® is helping our client, a global leader in testing and laboratory services located at St. Louis, with a Watson 7.6.1 system implementation and upgrade, including new servers, disaster recovery, computer system validation, and business process remediation. PSC™ had to support an aggressive project schedule and a global implementation team to ensured the project milestones were met with no loss to the overall project quality needed in an FDA-regulated environment. PSC™ accomplished this by using an IT-trained QA lead to manage the project from the QA and compliance perspective with one computer system validation resource to review post execution scripts and a Watson LIMS expert to advise and review the business process and standard operating procedures created by the client. This project required full PSC™ review and guidance on the technical details of the project and the entire computer system validation life cycle, including the validation plan, user requirements, testing protocols, and the release of the system with the approval of the final summary report.