This is a ready-to-use running log for tracking every signal a Continued Process Verification chart produces, from the specific rule that fired through to a documented, closed outcome. Replace every <<FILL: ...>> placeholder with your own specifics. Update it at every review cycle, and review the open and recently closed rows before every periodic review or annual product review, so a visible pattern with no recorded investigation is never the state a reviewer or an inspector finds. A filled specimen follows.
Instructions
Log every signal a monitored chart produces against the rules defined in the CPV plan, whether the outcome is a documented single-point assessment or a full investigation. A row is not removed from this log when an assessment or investigation reaches a conclusion; it moves to “closed” with the conclusion recorded, so the full history of what the chart showed and what was done about it stays visible across the product’s commercial life. Retain per <<FILL: document retention period>>.
Field definitions
| Field | Format | Required | Who completes it | When |
|---|---|---|---|---|
| ID | <<FILL: sequential, e.g. CPV-SIG-014>> | Yes | CPV program owner | At signal detection |
| Parameter | Name of the monitored CQA, CPP, or leading indicator | Yes | CPV program owner | At signal detection |
| Rule fired | <<FILL: e.g. single point beyond 3-sigma, 9 points one side of centerline, 6-point trend>> | Yes | Statistician or trained designee | At signal detection |
| Review cycle / date | <<FILL>> | Yes | CPV program owner | At review |
| Tier | <<FILL: single-point assessment / formal investigation>> | Yes | Process owner | At triage |
| Assignable cause investigated | Free text | Yes, for a formal investigation | Process owner / MSAT | During investigation |
| Outcome | <<FILL: explained, no action / CAPA opened / limit recalculation proposed>> | Yes | Process owner | At closure |
| CAPA or change control reference, if opened | <<FILL: system and number>> | Yes, if applicable | Process owner | At closure |
| QA review and disposition | Free text | Yes | Quality Assurance | At closure |
| Status | <<FILL: open / under investigation / closed>> | Yes | CPV program owner | Ongoing |
Log
| ID | Parameter | Rule fired | Review cycle | Tier | Investigation | Outcome | CAPA/CC ref | QA disposition | Status |
|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Two rows from an example oligonucleotide drug substance program’s log. Company and numbers are illustrative.
| ID | Parameter | Rule fired | Review cycle | Tier | Investigation | Outcome | CAPA/CC ref | QA disposition | Status |
|---|---|---|---|---|---|---|---|---|---|
| CPV-SIG-014 | Full-length purity, ion-exchange chromatography | Single point at 98.9%, above the 98.6% control limit, within the 90.0 to 100.0% specification | <<FILL: date>> | Single-point assessment | Reviewed against the batch record; coincided with a documented column regeneration performed one cycle early | Explained, no action; column regeneration timing noted for trend watch | N/A | Assessment accepted; regeneration timing added as a watch item for the next three batches | Closed |
| CPV-SIG-015 | Full-length purity, ion-exchange chromatography | Six consecutive points trending upward, most recent at 98.7% | <<FILL: date>> | Formal investigation | Traced to a new resin lot installed two cycles prior, showing a slightly higher binding capacity than the qualified lot | CAPA opened; resin lot qualification range narrowed, incoming resin lot testing added | CAPA-2026-0143 | Root cause accepted; control limits not recalculated, since the resin qualification range is being tightened instead of the process moving | Closed |
The specimen shows the distinction the log exists to enforce: CPV-SIG-014 closed as a documented single-point assessment with a specific, checkable explanation, while CPV-SIG-015 escalated to a formal investigation and a CAPA rather than being explained away with the same light-touch review. Neither row treats the control limit as something to move; the second row fixes the resin qualification instead.
Common inspection findings this log prevents
- A chart with a visible pattern spanning many batches and no row in any log showing it was ever investigated.
- A signal explained verbally at a team meeting with no documented basis, indistinguishable later from a signal nobody looked at.
- A single-point assessment and a formal investigation not distinguished anywhere in the record, so a reviewer cannot tell which response tier was actually applied.
- A CAPA number referenced in a CPV report with no corresponding row here connecting the chart signal that triggered it.
How to adapt this log
- Set the tier definitions and rule list to match the escalation rules stated in your own CPV plan; do not invent a different rule set for the log than the plan actually uses.
- Log every signal that fires, including ones later explained as noise. A log that only records investigations makes the single-point assessments invisible, which is itself a gap an inspector can find.
- Review all open rows before every periodic review and before the annual product review, not only when a new signal appears.
- Never edit a closed row’s original entry when new information emerges; add a follow-up row referencing the original ID instead, the same way a corrected batch record entry works.