Be compliant with Japanese CSV and ER/ES regulations and GS1 standards for best-in-class quality control to prevent flow of counterfeit drugs and ensure patient safety using our one-stop solution - PSchouette.



PSchouette is a label printing and verification package solution to ensure regulatory compliance for pharmaceutical and medical device companies. 

 

    

                                                                 


  • Support GS1-128, GS1 Datamatrix label printing with various designs to cater to customer’s requirements and needs.

  • System stops when error is detected and voids the defective label with cross markings to prevent misuse. 


  • PSchouette supports CSV (Computerised System Validation) and is developed to be compliant with ISO9001:2015 Quality Management System under Japan MOH guideline.
  • Validation is performed at the stage of system development to assure quality.


  • Audit logs are not provided in .txt or editable formats so as
    to prevent data manipulation or tampering.
  • Logs of system operations (login/logout, creation/
    modification/deletion of master data, password change/reset),
    label print history and label verification result history
    are recorded automatically and can be viewed or printed
    out as reports.



 Login screen                                        Functions controlled by user's role          Examples of error messages

                       
For more information, please feel free to drop us an email at salesorder-svs@sato-global.com