Axys-Network – Aseptic process consulting
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Inspection readiness

Prepare for your ANSM inspection with former inspectors

A simulated inspection, run exactly like an ANSM inspection and led by former ANSM and ANSES inspectors, followed by recommendations based on agency doctrine and interpretation.

Training your teams

Unannounced or announced, the assignment can cover a system, product or FDA-style inspection. Your teams practise interviews with the inspector, understand the inspector's point of view and the significance of an observation, and learn to group observations to build a diagnosis of strengths and weaknesses.

How the assignment runs

  1. 1Initial contact with the Qualified Person: objectives and potential weaknesses of the site.
  2. 2Preparation of the inspection programme from the layouts, the last report, recent changes and the master procedures. The schedule is not shared with the teams.
  3. 3On-site workshop of half a day: front room / back room, behaviour, how to answer.
  4. 4On-site inspection, with a 30-minute daily debrief to consolidate observations and launch corrections.
  5. 5Closing meeting : observations, criticality and solutions presented by your managers.
  6. 6Inspection report within one month: observations classified and ranked, risk factors.
  7. 7Feedback day : assessment of your action plan.