Regulatory library

EudraLex Volume 4, Annex 11

Annex 11 covers computerized systems. It asks for risk management across the system's life, validation, supplier assessment, audit trails, access control, data backup and periodic review.

ValDoc's library holds 7 provisions of EudraLex Volume 4, Annex 11. It can apply to URSs for biosafety cabinets, centrifuges, cryogenic systems, controlled temperature units, environmental monitoring, incubators, label printers, stability chambers, sterilization equipment, transport systems, thermal sealing and welding systems and vacuum pumps, depending on their intended use. This page is guidance in our words. The regulation's own text governs.

Last updated

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Equipment it reaches

Baseline requirements that cite it

  • The system shall be validated for intended use and provide authorized access, controlled configuration, verified calculations/interfaces and tested backup/restore.
  • Critical cycle recipes shall be version-controlled and restricted to authorized change; executed cycle identity and critical results shall be retained.
  • Authorized recipes shall define and execute the required cooling/holding profile; actual profiles and deviations shall be captured.
  • and 20 more

Provisions in ValDoc's library

  1. EU GMP Annex 11 Principle; §1

    Effective JAN2011

    Open the European Commission siteLast checked

  2. EU GMP Annex 11 §§3.1–3.4

    Effective JAN2011

    Open the European Commission site

  3. EU GMP Annex 11 §§4.3–4.4

    Effective JAN2011

    Open the European Commission siteLast checked

  4. EU GMP Annex 11 §§4.7–4.8;5–6

    Effective JAN2011

    Open the European Commission siteLast checked

  5. EU GMP Annex 11 §§7–9;17

    Effective JAN2011

    Open the European Commission siteLast checked

  6. EU GMP Annex 11 §§10–13

    Effective JAN2011

    Open the European Commission siteLast checked

  7. EU GMP Annex 11 §§14–16

    Effective JAN2011

    Open the European Commission siteLast checked

Other regulations

Every regulation in ValDoc's library

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Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.

Thirty minutes. Bring one piece of equipment.