FluVax FDA Compliance

Project Outline:

• Synertec provided the strategic design required to network all of the separate IVV automation systems spread across the various manufacturing buildings together with centralised services for user administration and security and historical recording and reporting.
• In conjunction with the compliance upgrade works, Synertec also provided automation and electrical services for a new plant extension to the Flu manufacturing facility
• Synertec has worked on a very aggressive timeline to upgrade all systems with new versions of SCADA systems which have had additional engineering applied to bring them into compliance with 21 CFR Part 11.
• Synertec is installing a number of new Siemens PCS 7 systems to provide EMS monitoring for new areas of the facility which also require FDA compliance.
• Significant effort was made to ensure the systems and documentation handed over are designed in such a way as to best facilitate maintaining ongoing compliance by CSL. This involved moving away from a project based delivery model and focusing on plant based document and information systems. Synertec is providing CSL with significant IP in this area as part of the project delivery
• The outcome was  a compliant strategy for automation systems across the entire Parkville site with common and centralised administration and maintenance functions. Documentation was provided in accordance with the GAMP V Model but was plant centric, not project centric. The documentation systems allow for future upgrade projects to modify the existing documentation rather than produce new and unwanted documentation. The documents are effectively considered a part of the physical plant in the same way as a valve or pump.

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