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MD 010 Design Validation Sop 1 0 110905125013 Phpapp02
MD 010 Design Validation Sop 1 0 110905125013 Phpapp02
Design Validation
Additional potential Hazards or Failure Modes may be discovered during Validation
activities. Some previously identified Hazards or Failure Modes may be observed or
estimated to have a frequency greater than previously anticipated. Risk Analysis
documentation shall be updated as necessary.
All products subject to Validation studies should be properly labelled and all equipment,
tools, and fixtures used in Validation must be documented and traceable to calibration
and maintenance records.
Validation testing should include simulation of expected environmental conditions such
as temperature, humidity, shock, vibration, etc. These environments may be
encountered during use or during shipping and storage.
Validation testing should include product labelling and packaging. These may have
human factors implications and may affect product performance.