This is a ready-to-use regulatory reporting log. A single log that lists every report owed, its clock, and its proof of submission is what lets an inspector (or you) see at a glance that nothing is open past due. Replace every <<FILL: ...>> placeholder and adapt the fields to your systems. A filled sample row follows. This is general guidance to adapt, not legal advice.
Control header
| Field | Entry |
|---|---|
| Log number | <<FILL: LOG-ID>> |
| Owner | <<FILL: Regulatory reporting / Field Alert coordinator>> |
| Governing SOP | <<FILL: SOP-ID for regulatory reporting>> |
| Retention | <<FILL: per records retention schedule, not less than the longest applicable reporting-record rule>> |
Field definitions
| Field | Format | Required | Who enters | When |
|---|---|---|---|---|
| Log ID | Sequential | Yes | Coordinator | At event screen |
| Trigger event reference | Deviation / complaint / OOS / AE number | Yes | Coordinator | At screen |
| Product / lot / application | Text; NDA/ANDA/BLA number | Yes | Coordinator | At screen |
| Report type | FAR / BPDR / 15-day / Recall / 506C / 5-day partner / other | Yes | Coordinator | At screen |
| Day-zero date | Date; receipt or discovery, per report type | Yes | Coordinator | At screen |
| Day-zero basis | Text; how day zero was determined | Yes | Coordinator | At screen |
| Clock | Text; e.g. 3 working days, 45 calendar days | Yes | Coordinator | At screen |
| Due date | Date; computed from day zero and the clock | Yes | Coordinator | At screen |
| Reportability decision | Report / Not report, with rationale reference | Yes | Decision-maker | Same day |
| Filed date | Date | If reported | Filer | On filing |
| Submission proof reference | Acknowledgment / confirmation ID | If reported | Filer | On filing |
| Status | Open / Filed initial / Follow-up / Final / Closed / Not reportable | Yes | Coordinator | Ongoing |
| Follow-up due (if any) | Date | If applicable | Coordinator | As needed |
Instructions
- Open a log row the day an event is screened, before the reportability decision is finalized, so a started clock is never invisible.
- Compute the due date from day zero and the clock immediately. For working-day clocks (FAR), exclude weekends and federal holidays.
- Record a “Not reportable” decision with its rationale reference; do not delete the row.
- On filing, record the filed date and the submission proof reference (the acknowledgment, not just an internal note).
- Keep FAR rows open through follow-up and final; a filed initial FAR with no final FAR is a common finding.
- Review the log on a defined cadence (
<<FILL: weekly>>); anything approaching or past due escalates to<<FILL: role>>. - Reconcile against the complaint and safety systems on a defined cycle so no case falls between systems.
Retention
Retain per <<FILL: retention schedule>>, not less than the longest retention any applicable reporting regulation requires for the underlying report.
Filled sample rows
Illustrative rows for the distributed cell-therapy sterility failure used across this topic.
| Log ID | Trigger | Product / lot | Report type | Day zero | Clock | Due | Decision | Filed | Proof | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| RR-2026-088 | OOS-2026-0451 | Cell therapy, lot B-2207, BLA <<FILL>> | BPDR | 30 Jul 2026 (discovery) | 45 cal days | 13 Sep 2026 | Report (safety/purity may be affected) | <<FILL>> | <<FILL: eBPDR conf>> | Open |
| RR-2026-089 | OOS-2026-0451 | Cell therapy, lot B-2207 | Recall notice | 31 Jul 2026 (recall decision) | Immediate (24h practice) | 01 Aug 2026 | Report (risk to health) | 31 Jul 2026 | District call note DCN-0217 | Filed initial |
| RR-2026-090 | OOS-2026-0451 | Cell therapy, lot B-2207 | 15-day safety | Conditional | 15 cal days from first receipt | On trigger | Watch: PV monitoring exposed patients | n/a | n/a | Open (conditional) |
| RR-2026-091 | OOS-2026-0451 | Cell therapy, lot B-2207 | 506C shortage | 30 Jul 2026 (interruption known) | As soon as practicable | Assess | Not reportable (small autologous, not covered), basis RA-memo-0088 | n/a | n/a | Not reportable |
The four rows from one event show the log’s whole value: the clocks run in parallel, the “not reportable” 506C call is captured with a rationale reference rather than left blank, and the recall row already carries its proof of submission.
Common inspection findings this log prevents
- A started clock that no one noticed because nothing was logged until the filing.
- A filed initial FAR with no final FAR, left open for years.
- A “not reportable” call with no recorded basis.
- Reports filed but no proof of submission retained, so timeliness cannot be shown.
How to adapt this log
- Match the report-type list to your product portfolio (add regional reports if you distribute ex-US).
- Automate the due-date computation where you can, and set the review cadence and escalation role.
- Keep the log and the reportability decision records cross-referenced.
- Retain per your schedule and the longest applicable regulatory retention.