Ravngard

Annex 11 readiness check

Ten questions about how your site manages computerised systems. Answer honestly — your answers stay in your browser and are never sent to us.

  1. Do you keep an up-to-date inventory of all GxP computerised systems, with their GxP impact and owner?

    Annex 11 §4.3
    Do you keep an up-to-date inventory of all GxP computerised systems, with their GxP impact and owner?

  2. Is there a documented risk assessment for each system that decides how much validation it needs?

    Annex 11 §1
    Is there a documented risk assessment for each system that decides how much validation it needs?

  3. Can you trace every user requirement to the tests that verify it?

    Annex 11 §4.4–4.5
    Can you trace every user requirement to the tests that verify it?

  4. Have you assessed the suppliers of your GxP systems and agreed responsibilities in writing?

    Annex 11 §3
    Have you assessed the suppliers of your GxP systems and agreed responsibilities in writing?

  5. Are audit trails enabled on GxP systems and reviewed regularly?

    Annex 11 §9
    Are audit trails enabled on GxP systems and reviewed regularly?

  6. Does every user have a personal account, with access reviewed periodically?

    Annex 11 §12
    Does every user have a personal account, with access reviewed periodically?

  7. Are electronic signatures linked to their record, with name, date, time and meaning?

    Annex 11 §14
    Are electronic signatures linked to their record, with name, date, time and meaning?

  8. Are backups tested by actually restoring data?

    Annex 11 §7.2
    Are backups tested by actually restoring data?

  9. Are changes to GxP systems handled through change control with impact assessment?

    Annex 11 §10
    Are changes to GxP systems handled through change control with impact assessment?

  10. Is every system periodically reviewed on time?

    Annex 11 §11
    Is every system periodically reviewed on time?

This check is a self-assessment aid based on EU GMP Annex 11 (2011). It is not an audit and does not replace your own quality system.