This is a ready-to-use form for the applicability gate in a regulatory intelligence program. It turns an external finding into a documented decision: act, monitor, or record as not applicable with rationale. Replace every <<FILL: ...>> placeholder, then route completed forms into your regulatory intelligence signal register. A filled specimen follows the blank form.
Form control
| Field | Entry |
|---|---|
| Form number | <<FILL: FORM-ID, e.g. FRM-QA-051-01>> |
| Parent SOP | <<FILL: SOP-ID for the RI program>> |
| Version / effective date | <<FILL>> |
Section A: Signal identification
| Field | Format | Entry |
|---|---|---|
| Signal ID (register key) | text | <<FILL: RI-2026-nnn>> |
| Source document type | 483 / Warning Letter / EIR / EU or UK deficiency / Guidance | <<FILL>> |
| Issue date | date | <<FILL>> |
| Issuing authority / office | text | <<FILL>> |
| Subject firm type / product | text (no confidential detail) | <<FILL>> |
| Cited regulation(s) | text | <<FILL: e.g. 211.192, Part 11>> |
| Failure theme (taxonomy) | controlled list | <<FILL>> |
| Mechanism (verbatim where possible) | free text | <<FILL>> |
| Escalation outcome | 483 closed / OAI / Warning Letter / import alert / other | <<FILL>> |
Section B: Applicability gate
Answer in order. The first “No” that ends the assessment sets the disposition.
| # | Question | Answer | Evidence / rationale |
|---|---|---|---|
| B1 | Does the cited process or system exist in our operation? | Yes / No | <<FILL>> |
| B2 | (If B1 Yes) Do we have the same or a similar control gap? A targeted self-check was performed. | Yes / No / Self-check pending | <<FILL: what was checked, by whom, what was found>> |
| B3 | Self-check reference (record / date / performer) | text | <<FILL>> |
If B1 is No: disposition is Not applicable. Record the rationale and close. If B1 Yes and B2 No: disposition is Monitor. Keep the signal on the watch list. If B1 Yes and B2 Yes: continue to Section C.
Section C: Risk rating (applicable signals only)
Use the company quality risk management scales. Enter the rating as assessed for the gap as it exists here, not as it existed at the cited firm.
| Factor | Rating | Basis |
|---|---|---|
| Severity (impact on data, decision, product, or patient) | <<FILL: High / Med / Low or numeric>> | <<FILL>> |
| Probability / likelihood of occurrence | <<FILL>> | <<FILL>> |
| Detectability (how likely current controls catch it) | <<FILL>> | <<FILL>> |
| Resulting risk level / priority | <<FILL>> | <<FILL>> |
Section D: Disposition and routing
| Field | Entry |
|---|---|
| Disposition | Applicable / Monitor / Not applicable |
| Routing (tick all that apply) | Preventive CAPA / Risk register update / Change control / Internal audit scope / Inspection-readiness briefing |
| CAPA number (if raised) | <<FILL or N/A>> |
| Change control number (if raised) | <<FILL or N/A>> |
| Risk register entry (if raised) | <<FILL or N/A>> |
| Effectiveness check defined? | Yes / No / N/A |
| Target closure date | <<FILL>> |
Section E: Approval
| Role | Name | Signature | Date |
|---|---|---|---|
| Assessed by (RI analyst / SME) | <<FILL>> | ||
| Reviewed / approved by (RI lead or QA) | <<FILL>> |
Retention: retain per the records retention schedule, not less than <<FILL: retention period>>. Store where an inspector can retrieve it, including the Not-applicable assessments.
Filled specimen
The following shows the form completed for a rising warning-letter theme. Company, numbers, and names are illustrative.
Section A. Signal ID RI-2026-047. Source: Warning Letter, 14 May 2026, drug GMP, oral-solids contract manufacturer. Cited 211.194(a) and Part 11. Failure theme: DI, audit trail review not performed. Mechanism: “audit trails in the chromatography system were not reviewed as part of analytical data review; response lacked a retrospective batch review.” Escalation: Warning Letter (response judged inadequate).
Section B.
| # | Question | Answer | Evidence / rationale |
|---|---|---|---|
| B1 | Cited process/system exists here? | Yes | Three chromatography data systems, one LIMS in the QC lab |
| B2 | Same control gap? | Yes | Self-check found audit trail review undocumented for the HPLC-07 workflow |
| B3 | Self-check reference | SC-2026-018, 20 May 2026, performed by QC data-integrity SME |
Section C.
| Factor | Rating | Basis |
|---|---|---|
| Severity | High | Data integrity; affects release-testing results |
| Probability | Medium | Gap confirmed for one of four systems |
| Detectability | Low | No routine audit trail review documented for that workflow |
| Risk level | High | Priority action |
Section D. Disposition: Applicable. Routing: Preventive CAPA + Change control + Internal audit scope. CAPA-2026-0188. CC-2026-0140. Effectiveness check defined: Yes (sample 20 reviews at 90 days). Target closure 30 Sep 2026.
Section E. Assessed by QC DI SME; approved by RI lead, 21 May 2026.
Common inspection findings this form prevents
- A visible enforcement trend that was clearly tracked but never triaged into a decision.
- No documented rationale for the signals the firm chose not to act on.
- Risk rated from the cited firm’s situation rather than the firm’s own confirmed gap.
- Applicable signals with no traceable CAPA, change, or risk-register number.
How to adapt this form
- Set the form number and parent SOP in the control block.
- Replace the risk scales in Section C with your own QRM rating definitions.
- Constrain the failure-theme field to your controlled taxonomy list.
- Wire the routing fields to your real CAPA, change-control, and risk-register identifiers.