Role-Based Programme
RB1573

AI-Powered Quality Management System Administration

Smarter QMS Documentation, Compliance & Workflow Control

IMAGE REQUIRED
Duration
8 Hours
Level
Basic
Delivery
Instructor-Led
Format
Workshop

Programme Objectives

  • Understand how AI can support Quality Management System Administration across documentation, records, compliance, audits, CAPA, and reporting.
  • Apply AI-assisted techniques to organise QMS documents, review procedures, extract requirements, identify gaps, and track quality actions.
  • Use structured prompting for SOP review, document comparison, quality-record analysis, audit preparation, and management reporting.
  • Explore AI-supported approaches for monitoring document status, non-conformances, CAPA, training records, and QMS performance indicators.
  • Build responsible AI-assisted QMS workflows while maintaining document control, traceability, accuracy, approvals, and human oversight.

Tools covered

Generative AI AssistantsAI Search & ResearchDocument AISpreadsheet & Data AnalysisQMS Documentation AnalysisAudit & Compliance SupportCAPA TrackingWorkflow Automation

Who should attend

  • QMS Administrators
  • Quality Systems Executives
  • Quality Systems Coordinators
  • Quality Assurance Professionals
  • Quality Documentation Professionals
  • Quality Executives
  • Document Control Professionals
  • Quality Auditors
  • CAPA Coordinators
  • Compliance Professionals
  • Process Quality Professionals
  • Quality Managers
  • Process Owners
  • Quality Management System Team Leads

Prerequisites & Participant Readiness

  • Basic understanding of Quality Management Systems or quality-assurance activities
  • Familiarity with SOPs, controlled documents, quality records, audits, CAPA, or document registers is helpful
  • Basic computer, spreadsheet, and document-handling skills
  • No AI or programming knowledge required
  • No previous AI training required

TOC Modules

Concepts
  • Understanding Generative AI and its relevance to Quality Management System Administration
  • Identifying AI applications across document control, records, audits, CAPA, compliance, and reporting
  • Understanding AI assistance versus Quality professional and process-owner judgement
  • Recognising limitations such as hallucinations, incomplete evidence, and unsupported compliance conclusions
Practical activities
  • Mapping a typical QMS administration workflow
  • Identifying repetitive and information-intensive QMS activities suitable for AI assistance
  • Comparing a traditional QMS task with an AI-assisted approach

Scenarios

QMS Document Review to Controlled Update

Existing SOP → AI-Assisted Review → Version Comparison → Identified Changes → Owner Review → Approval → Updated Register

Participants use AI to review and compare sample QMS documents, identify changes and gaps, and prepare structured information for controlled document revision.

QMS Records to Management Review

Document Register + Audit Findings + CAPA Status + Quality Records → AI Analysis → Overdue Items → Recurring Issues → Priority Actions → Management Summary

Participants use AI to analyse sample QMS information, identify open and recurring quality-system issues, and prepare a management-ready QMS Administration report.

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