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Computer System Validation for a pharmaceutical client – PSC Biotech

About this Project


Installation and qualification documents for the new UDI Carton Printer and Verification Systems. 


There were different stages in the installation and qualification of documents related to the UDI Carton Printer and Verification systems. We wrote all the User Requirement Specifications (URS’s), FDS’s, IOQ’s and TM’s for the system. In addition, we also created all the Equipment Identification Forms (EID) and Standard Operating Procedures (SOPs). Next, we developed and installed recipes and performed troubleshooting with their automation engineers during the execution phases of the project. Lastly, we trained production personnel on the operation of the UDI Carton Printer & verification Systems. 


The client was very satisfied with the outcome and praised PSC Biotech for its professionalism, expertise and customer-centric approach. The project was completed on time and within budget, and we are very happy with the outcome.