Validation Framework

GAMP 5 Validation Approach

Antaris provides a Validation Framework for our customers in the pharmaceutical market, based on the GAMP 5 (Good Automated Manufacturing Practice) validation approach. The framework includes the required deliverables for the validation of the SmartView system.

The validation framework consists of:

  • Validation Plan: detailed description of validation strategy, required validation deliverables and roles & responsibilities
  • Risk Analysis document: a Risk Assessment, based on a Failure Mode and Effect Analysis, detailing the risk scenario’s and required control for each requirements stated in the User Requirement Specifications document
  • Verification protocols and –reports (IQ/ OQ/ PQ).
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