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GxP Validation Assistant

The US package · United States

21 CFR Part 11, the CGMP computer rules and FDA guidance, on the international core.

For sites inspected by FDA. The package adds Part 11 and the computer-related requirements of Part 211 to the core, with FDA's guidance on Part 11 scope, data integrity and computer software assurance, and offers the published drafts and AI as overlays. Documents on Letter paper, in American English.

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Regulators
FDA
Languages
American English
Paper
Letter

  • Every section, paraphrased

    Part 11 and Part 211 as rule packs, each rule citing its section; the guidance next to them, labeled as guidance.

  • Assurance scaled to risk

    Intended use first, then scripted or unscripted testing by risk, with the record FDA's assurance guidance describes.

  • Electronic signatures your way

    Sign on paper or in your validated system, or switch on signing in the application; the electronic records procedure covers the certification letter to FDA.

Contents

What the US package contains

The core and the package's own rule packs, by status. Each rule is paraphrased with its section number, cites its source and names its status; documents name the packs they are written against.

US package

  • 21 CFR Part 11: electronic records, electronic signatures

    Version 1997-08-20 v3.1 · 25 rules

    In force

  • 21 CFR Part 211 (CGMP for finished pharmaceuticals): computer-related requirements

    Version 2008-09-08 v3.1 · 12 rules

    In force

  • FDA guidance: computer software assurance for production and quality management system software (2026)

    Version 2026-02-03 v3.1 · 11 rules

    Guidance

  • FDA guidance: data integrity and compliance with drug CGMP (2018)

    Version 2018-12 v3.1 · 19 rules

    Guidance

  • FDA guidance: Part 11 scope and application (2003)

    Version 2003-08 v3.1 · 10 rules

    Guidance

International core

  • ICH Q10 (2008): pharmaceutical quality system

    Version 2008-06-04 v3.1 · 7 rules

    Guidance

  • ICH Q9(R1) (2023): quality risk management

    Version 2023-01-18 v3.1 · 10 rules

    Guidance

  • PIC/S PI 011-3: good practices for computerised systems (2007)

    Version 2007-09-25 v3.1 · 24 rules

    Guidance

  • PIC/S PI 041-1: data management and integrity (2021)

    Version 2021-07-01 v3.1 · 30 rules

    Guidance

  • WHO guideline on data integrity (TRS 1033, Annex 4, 2021)

    Version 2021 v3 · 26 rules

    Guidance

Overlays, included

Switched on in setup where they apply to you; recommended ones are preselected.

  • Drafts

    Published drafts and consultations, advisory and labeled DRAFT, so you can prepare before they apply.

    • AI and machine learning

      AI and machine-learning use in GxP work, classified by AI level, with its evidence package.

      • FDA draft guidance: AI to support regulatory decision-making for drugs (2025)

        Version 2025-01 v1 · 13 rules

        Draft

    SOP set

    26 global procedures and 2 annex procedures for the package, adopted as drafts in setup, each citing the rules it covers. Overlays add their own procedures.

    The US package

    One license covers one installation and the package you buy, with every overlay that package offers. Try it first: every installation runs 14 days without a license.

    Every license includes

    • The program for Windows and Linux with checksums; a Docker image for a server on request
    • The international core and the package you buy, with all its overlays
    • English and the package's local languages, for the interface and the documents
    • Your license key straight away in the license portal, for the installation ID you enter
    • After the included update period: support and updates as a yearly subscription you can end at any time

    Questions about the US package

    Which texts in the US package are binding?

    21 CFR Part 11 and the computer-related requirements of 21 CFR Part 211 are in force. FDA's guidance on Part 11 scope and application, data integrity and computer software assurance is included and labeled as guidance; with the AI and drafts overlays, FDA's draft guidance on AI to support regulatory decision-making is added, labeled DRAFT.

    Does the assistant make our systems Part 11 compliant?

    No tool can. It helps you assess which systems hold records the predicate rules require, validate them in proportion to their risk, and keep the controls Part 11 expects (access, audit trails, signatures, records) documented and reviewed. Your company remains responsible.

    Can we use its electronic signatures for Part 11 records?

    You can switch on review and electronic signatures in the application: personal accounts, re-authentication at each signature, name, date, time and meaning on the document, the audit trail locked on, and optional two-factor sign-in. Your company validates that use with the validation kit and sends the certification letter to FDA.

    Why is the CSA guidance applied to drug companies?

    FDA wrote it for medical device production and quality system software. Its risk-based thinking is widely applied by analogy to other GxP software; the assistant includes it as guidance and says so.

    Topics

    Find out in one session whether it fits your department.

    The webinar walks through setup, a system from intended use to release, the documents and the IT controls that keep it validated.

    Choose a time