Regulatory library

21 CFR Part 58

Part 58 is FDA's good laboratory practice rule for nonclinical studies. It asks that study equipment be suitably designed and located, and that it be inspected, cleaned, maintained and calibrated under written procedures with records.

ValDoc's library holds 1 provision of 21 CFR Part 58. This page is guidance in our words. The regulation's own text governs.

Last updated

Thirty minutes. Bring one piece of equipment.

Provisions in ValDoc's library

  1. 21 CFR 58.61; 58.63

    Unchanged since

    Equipment design; Maintenance and calibration of equipment

    Open eCFR

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.