Role-Based Programme
RB1574

AI-Powered Quality Management System Administration

Smarter QMS Control, Documentation & Compliance Management

IMAGE REQUIRED
Duration
16 Hours
Level
Intermediate
Delivery
Instructor-Led
Format
Capability Training

Programme Objectives

  • Apply AI across Quality Management System administration including document control, records management, audits, CAPA, change control, training records, and compliance monitoring.
  • Use AI-assisted techniques to organise, review, compare, summarise, and track QMS documentation and quality records more efficiently.
  • Develop structured workflows for document approval, revision control, quality records, audit actions, CAPA, and management review.
  • Improve visibility into QMS status, overdue actions, document changes, recurring issues, and compliance gaps.
  • Apply responsible AI practices covering document accuracy, evidence integrity, traceability, access control, confidentiality, and human oversight.

Tools covered

Generative AI AssistantsQMS Documentation SupportDocument IntelligenceSpreadsheet AnalysisAudit & CAPA TrackingChange ControlCompliance MonitoringQuality AnalyticsReporting AssistanceWorkflow Automation

Who should attend

  • QMS Administrators
  • Quality Management System Coordinators
  • Quality Managers
  • Quality Assurance Professionals
  • Document Control Professionals
  • Quality Compliance Professionals
  • Quality Executives
  • Internal Quality Auditors
  • CAPA Coordinators
  • Quality System Professionals
  • Change Control Coordinators
  • Quality Analysts
  • Process Quality Professionals
  • Quality Management Team Leads

Prerequisites & Participant Readiness

  • Working knowledge of Quality Management Systems, quality documentation, or compliance activities
  • Familiarity with SOPs, records, audits, CAPA, document control, or change control is helpful
  • Basic document and spreadsheet skills
  • Basic awareness of Generative AI is helpful
  • No programming knowledge required

TOC Modules

Concepts
  • Understanding Generative AI, document intelligence, analytics, and automation in QMS administration
  • Identifying AI opportunities across document control, quality records, audits, CAPA, and reporting
  • Understanding AI assistance versus Quality Management System governance and professional accountability
  • Recognising risks related to inaccurate documentation, uncontrolled outputs, and poor evidence quality
Practical activities
  • Mapping QMS administrative activities to AI-assisted opportunities
  • Identifying repetitive QMS tasks suitable for AI support
  • Comparing traditional and AI-assisted QMS administration workflows

Scenarios

SOP Revision to Controlled Release

Change Request → AI-Assisted Document Review → Impact Assessment → Revision → Approval → Training Update → Controlled Release → Archive Previous Version

Participants manage a simulated SOP revision, identify affected processes and roles, prepare revision documentation, track approvals, and ensure controlled release with updated training requirements.

QMS Data to Management Review Pack

Audit Findings + CAPA + Document Status + Training Records + Change Controls → AI Analysis → Recurring Gaps → Overdue Actions → Priority Risks → Management Review Report

Participants consolidate QMS administrative information, identify recurring system weaknesses and overdue actions, and prepare a management-review pack with clear priorities, owners, and next steps.

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