A validation protocol is a document written and approved before any result is seen. Its order is:

  1. The product temperature range and how long the container must stay within it.
  2. Load and route: fill, starting temperature, ambient exposure, stops and the worst case for door openings.
  3. Sensor count and positions with a reason for each; alignment of device clocks.
  4. The acceptance criterion.
  5. Who assesses a deviation, and on which records.

An unsuitable result is recorded and the protocol is not rewritten afterwards; work after a correction runs as a new version. GEBHARDT offers process consulting and guided testing for the Isotec TBX, and Aris Makina passes the request on.