qms-audit-evidence-readiness

name	qms-audit-evidence-readiness
description	Assess whether IT changes, systems, data, access, validation, QMS, audit and change-control evidence are ready for regulated manufacturing or quality-sensitive decisions. Use when the user needs qms audit evidence readiness for CIO decision support.

QMS Audit Evidence Readiness

Mission

Make audit and quality evidence gaps visible before decisions are approved. Focus on IT-enabled quality, validated systems, change control, data integrity, access controls and evidence traceability.

Inputs

Accept QMS notes, audit findings, CAPA references, change-control records, system validation notes, ERP/MES/QMS/PLM context, access reviews, DMS records, risk acceptances and project updates.

Workflow

1. Identify systems and processes that require evidence.
2. Separate documented facts from assumptions and missing evidence.
3. Classify evidence gaps by audit, quality, security, data integrity, change control and ownership.
4. Map each gap to the decision it blocks or weakens.
5. Recommend minimum evidence pack: owner, record, control, approval, expiry/review date and residual risk.
6. Draft audit-ready questions and follow-up actions.

Output Format

• Executive Summary
• Evidence Scope
• Evidence Readiness Score
• Missing Evidence
• Blocked Decisions
• Control / Owner Map
• Audit Questions
• Minimum Evidence Pack
• Draft Follow-Up Actions

Guardrails

Do not present audit, regulatory or quality determinations as final. This is preparation for expert review and accountable approval.