LifeSciencesAIAcademy
Track 06Operational GuardrailsLocked by prerequisiteOptional

Context of Use

Teach learners to define, write and maintain a context-of-use statement — the single artefact that makes every other AI control possible.

5 lessons · 5 frameworks · 3–4 hours · 0/5 complete · 0/5 exercises recorded

Locked by prerequisite

This track opens once its prerequisites are complete. Prerequisites are sequenced deliberately: each one supplies a competency this track assumes you already hold.

  • Track 01 — AI Fundamentals
  • Track 02 — AI Governance & Regulatory Expectations
  • Track 05 — Risk Assessment & Risk Recognition

Orientation

Why this matters

Almost every regulatory question about AI reduces to one thing: what exactly is this model being used for, and how much does it influence the decision? An organisation that cannot answer precisely cannot validate, control or defend its use.

What you will be able to do (5)

  • Explain what context of use means and why regulators anchor on it
  • Define intended users, inputs, outputs and the decisions influenced
  • Determine whether a use crosses a GxP boundary
  • Anticipate foreseeable misuse and detect changed use
  • Write and maintain a context-of-use statement

Aligned with (5)

FDA — context of use and model influence conceptsICH Q9(R1) — risk-based decision makingGAMP 5 (2nd Edition) — intended use and categorisationEU GMP Annex 11 — system description and intended purposeISO/IEC 42001 — AI system scope definition

Maps to published expectations. Competency demonstrated through assessment.

Regulatory alignment indicates that curriculum topics map to published regulatory expectations. It does not constitute agency approval, certification, legal advice or a determination of organizational compliance.

View source evidence, status and applicability

FDA — context of use and model influence concepts

Draft regulatory guidanceUnited States
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products ↗
Relevant provisions
Step 1 — define the question of interest and context of use
Status and date
January 2025. Draft; not for implementation and non-binding.
Why it maps
Maps the lesson to FDA's context-of-use and credibility concepts without treating draft recommendations as law.
Applicability limit
Applies to AI used to produce information or data supporting FDA regulatory decisions for drugs and biological products. It is not a general AI-use mandate.

Primary source last verified 2026-08-24

ICH Q9(R1) — risk-based decision making

Harmonised guidelineICH regions; implemented through regional frameworks
ICH Q9(R1) — Quality Risk Management ↗
Relevant provisions
Sections 4–6 and Annexes I–II
Status and date
Step 4, 18 January 2023. Implementation depends on the relevant regional authority and regulated activity.
Why it maps
Supports the track's stated mapping to ICH Q9(R1) — risk-based decision making without transferring duties beyond the source's scope.
Applicability limit
Supplies quality-risk principles. It does not independently classify an AI system or prescribe one universal control set.

Primary source last verified 2026-08-24

GAMP 5 (2nd Edition) — intended use and categorisation

Industry guidanceInternational industry practice
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd ed. ↗
Relevant provisions
Lifecycle, intended use, critical thinking, supplier involvement and risk-based assurance
Status and date
July 2022. Non-binding unless adopted by an organisation, contract or authority.
Why it maps
Supplies a recognised management or assurance practice; it is identified as non-binding unless separately adopted.
Applicability limit
Widely used industry guidance. It must not be described as legislation or a regulator-issued mandate.

Primary source last verified 2026-08-24

EU GMP Annex 11 — system description and intended purpose

GMP requirementEuropean Union GMP
EudraLex Volume 4, Annex 11 — Computerised Systems ↗
Relevant provisions
Sections 4.3 and 4.4 — system description and specifications
Status and date
Revision January 2011. Current Annex 11; came into operation 30 June 2011.
Why it maps
Supports the track's stated mapping to EU GMP Annex 11 — system description and intended purpose without transferring duties beyond the source's scope.
Applicability limit
Applies to computerised systems used as part of GMP-regulated activities. Applicability follows the regulated process and intended use.

Primary source last verified 2026-08-24

ISO/IEC 42001 — AI system scope definition

Consensus standardInternational consensus standard
ISO/IEC 42001:2023 — Artificial intelligence management system ↗
Relevant provisions
Clauses 4–10 and Annex A controls
Status and date
December 2023. Voluntary unless adopted by contract, policy, certification scheme or applicable authority.
Why it maps
Supplies a recognised management or assurance practice; it is identified as non-binding unless separately adopted.
Applicability limit
Specifies requirements for an AI management system. Use of the standard does not itself establish regulatory compliance.

Primary source last verified 2026-08-24

Full source register and editorial method →

Credential

AI Context-of-Use Practitioner Badge

Duration

3–4 hours

Audience

  • Quality, validation and system owners
  • Process owners proposing AI use
  • Regulatory and clinical professionals

Prerequisites

  • Track 01
  • Track 02
  • Track 05

Behaviours practised (3)

UnderstandApplyDocument
Two sites use the same AI tool for 'deviation support'. At one site it suggests search terms for the investigator. At the other it drafts the root-cause conclusion. The tool is identical; the context of use is not, and only one of the two has been validated for what it actually does.

Badge requirements (5)

  1. Complete all five lessons and their knowledge checks
  2. Achieve at least 80% across the final badge assessment
  3. Answer every safety-critical question correctly
  4. Produce a complete context-of-use statement with exclusions and foreseeable misuse
  5. Correctly determine GxP relevance by tracing output downstream

Lessons (5)

Final badge assessment

AI Context-of-Use Practitioner Badge

  • Context-of-use adequacy

    Identify the unsupported statementSafety-critical

    Identify which of six statements meet the definition of a context of use and why.

  • GxP boundary determination

    Scenario classificationSafety-critical

    Determine GxP relevance for six uses by tracing output downstream.

  • Change-trigger recognition

    Select all that apply

    Identify which of eight changes require reassessment of a context of use.

  • Practical exercise — context-of-use statement

    Practical exercise

    Produce a complete, maintainable context-of-use statement for a stated pharmaceutical use.

Next recommended track

Track 07 — Human Accountability & Oversight
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