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Validation Kit

Validation_Kit

The Validation Kit, designed for all Standard Software Packages of Polisystem Informatica (C.O.T.S.) includes :

 

 

  • Documents of Software Production :
    • Establishment of critical SW requirements for compliance with the Regulations
      (Ex. GLP, UNI CEI EN ISO/IEC 17025, FDA CFR 21 Oart 11, …)
    • Design and Development Specifications
      1. List of main processes supported by SW
      2. General Specifications of SW Design
      3. Model of Main Data
      4. Type of User Manual
    • Opportunity to consult (on request by the Inspection Bodies) I.T. Tests (Test of the Programmer) made by us through the package “ValSW”
    • Report Correlation Matrix between Standards and Processes / steps / operations support by the Software in accordance with the Legislation itself
  • Pantry-depth activity of Software Validation (slides)
 
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