Validation

Stilmas can offers a wide range of services related to validation through its organization, specialized in functional areas.

cGMP COMPLIANCE & VALIDATION AREA

Stilmas cGMP Compliance & Validation area organizes and develops validation activities with the “Validation Life-Cycle Approach”, which sees Validation as a traceable and documented evidence for all the activities developed during Life-cycle systems, from the user requirements definition up to the validation maintenance during the routine operation of the system.

Stilmas can organize and implement the following activities:

  • Training program of personnel on validation and GMPs related topics
  • Validation master plan preparation
  • User requirements specification preparation (URS)
  • Functional & design specification preparation (FDS)
  • Design qualification (EDR: Enhanced Design Review)
  • Validation protocols preparation, “Site” tests execution & validation reports preparation for:
    • Installation Qualification (IQ);
    • Operational Qualification (OQ);
    • Performance Qualification (PQ);
    • Process Validation (PV).
  • Planning & Execution of instruments calibration at final user site
  • Computerized control system validation as per GAMP and 21CFR part.11 requirements

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