Regulatory library

21 CFR Part 11

Part 11 sets the conditions under which FDA accepts electronic records and electronic signatures in place of paper. For equipment that stores GMP data it asks for validated systems, secure audit trails, access controls and signatures linked to their records.

ValDoc's library holds 5 provisions of 21 CFR Part 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

Thirty minutes. Bring one piece of equipment.

Equipment it reaches

Baseline requirements that cite it

  • The system shall protect required records and metadata, provide complete accurate copies and protected time-stamped change history where applicable; signatures shall remain linked to records if used.
  • Electronic records shall preserve attributable temperature/humidity histories, relevant configuration changes and interruptions throughout the defined retention period.
  • Cycle recipes shall be approved/version controlled; records shall identify load, cycle, equipment, operator, critical parameters and outcome, including failures.
  • and 3 more

Provisions in ValDoc's library

  1. 21 CFR 11.1(b)-(e)

    Effective

    Scope

    Open eCFRLast checked

  2. 21 CFR 11.10(a)-(e)

    Unchanged since

    Controls for closed systems

    Open eCFRLast checked

  3. 21 CFR 11.10(f)-(k)

    Unchanged since

    Controls for closed systems

    Open eCFR

  4. 21 CFR 11.30

    Unchanged since

    Controls for open systems

    Open eCFRLast checked

  5. 21 CFR 11.50; 11.70; 11.100; 11.200; 11.300

    Effective

    Signature manifestations; Signature/record linking; General requirements; Electronic signature components and controls; Controls for identification codes/passwords

    Open eCFRLast checked

Other regulations

Every regulation in ValDoc's library

See your own equipment in ValDoc.

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.