Regulatory library

FDA guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application

FDA's guidance on how it reads Part 11. It narrows the rule to records that predicate rules require, and asks for a risk-based approach to validation, audit trails and record retention.

ValDoc's library holds 1 provision of FDA guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application. 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. FDA guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application, Sections II–III

    Effective AUG2003

    Part 11, Electronic Records; Electronic Signatures — Scope and Application

    Open the FDA site

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.