Checklist Rules
Your own checklist items, added on top of the Rimsys regulatory checklist. Active rules are applied automatically whenever a gap assessment runs on a matching submission.
5 rules
| ID | Rule | Applies to | Source | Severity | Status | |
|---|---|---|---|---|---|---|
| CR-001 | Subcontractor sterilisation validation must include EO residual test reports | EU MDR Sterile, Class III Section: Quality Management | Notified Body finding DEKRA deficiency letter NB-2024-Q3-118 (12 Apr 2024) | Blocker | Active | Edit |
| CR-002 | Quality agreement with each critical supplier must be cited by document number | All All products Section: Quality Management | Internal SOP SOP-8812 Supplier Controls, rev. F | Warning | Active | Edit |
| CR-003 | Declaration of Conformity must list the Basic UDI-DI | EU MDR All products Section: Declarations of Conformity | Notified Body finding BSI technical review TR-2025-0441 | Blocker | Active | Edit |
| CR-004 | Accelerated aging protocol must state Q10 and chamber humidity | US FDA Sterile, Vascular catheter All sections | Authority deficiency FDA AI request K241133 — Deficiency 4 | Blocker | Active | Edit |
| CR-005 | Cybersecurity SBOM must be attached for connected devices | US FDA Software (SaMD) All sections | Internal SOP SOP-9020 Cybersecurity, rev. B | Warning | Draft | Edit |
See it in action: open SUB-054 and run the AI Gap Assessment on section 1.4 — company rules appear in the Regulatory checklist with their own badge.