| 4.1–4.2 |
Impartiality, Independence & Confidentiality |
Independence & Impartiality Verification Checklist |
MODIFIED — Type A / non-Type A |
| 5.1–5.3 |
Legal, Contractual Matters & Scope |
Transition Readiness + Document Requirements Matrix |
MODIFIED |
| 6.1 |
Personnel — Competence & Authorisation |
Personnel Competence Checklist |
MODIFIED — "access to" + per-activity authorisation |
| 6.2 |
Facilities, Equipment & Technology |
Technical Data Control Checklist |
MODIFIED — software validation, digital tools |
| 6.3 |
Subcontracting & External Providers |
External Provider Checklist |
MODIFIED — strengthened controls |
| 7.1–7.4 |
Inspection Methods, Records & Reports |
Technical Data Control + Document Requirements Matrix |
MODIFIED — digital records, data integrity |
| 7.5 |
Technology & Remote Inspections |
Remote Inspection Protocol |
NEW — entire new requirement in 2026 |
| 8.1–8.3 |
Management System, Documentation & Records |
Document Requirements Matrix |
MODIFIED — Option A/B alignment |
| 8.4 |
Management Review |
Management Review Audit Checklist |
MODIFIED — 5 new mandatory inputs |
| 8.5 |
Internal Audits |
Internal Audit Checklist |
MODIFIED |
| 8.6 |
Corrective Action & Risk-Based Thinking |
Transition Readiness Checklist |
MODIFIED — risk-based approach replaces preventive action |
| 8.7 |
Complaints & Appeals |
Internal Audit Checklist |
MODIFIED — publicly available processes required |
| Annex A |
Independence Classification (Type A / non-Type A) |
Independence & Impartiality Verification Checklist |
RESTRUCTURED — replaces Type A / B / C |