Description
Inspect supplied CAPA review scheduling metadata without determining effectiveness or compliance.
Quality records separate measured results, reference values, acceptance rules, and supporting evidence. Arithmetic consistency and record coverage can be checked against supplied criteria without establishing traceability, approving a method, or deciding product conformity.
Inspect supplied CAPA review scheduling metadata without determining effectiveness or compliance.
When to use this tool
Use it for capa effectiveness review gap when the required inputs and conventions are already available.
How to use the tool and how it works
- Enter actionClosed, reviewTime, suppliedMinimumInterval. Use the stated units and boundary conventions.
- Run the calculation. Correct any input error before interpreting a result.
- Read elapsed, intervalMargin. Inspect any known, defined, inclusion, or boundary flags before interpreting numeric values.
Require nonnegative suppliedMinimumInterval. Return elapsed=reviewTime-actionClosed and intervalMargin=elapsed-suppliedMinimumInterval.1
| Input field | Meaning and units | Accepted input |
|---|---|---|
| actionClosed | Action Closed | Required. Finite number. |
| reviewTime | Review Time | Required. Finite number. |
| suppliedMinimumInterval | Supplied Minimum Interval | Required. Finite number; minimum 0. |
| Output field | Interpretation | Returned shape |
|---|---|---|
| elapsed | Elapsed | Required. Finite number. |
| intervalMargin | Interval Margin | Required. Finite number. |
{
"input": {
"actionClosed": 100,
"reviewTime": 130,
"suppliedMinimumInterval": 20
},
"output": {
"elapsed": 30,
"intervalMargin": 10
}
}Limitations and assumptions
- A review before closure is permitted and produces negative elapsed. The tool does not verify the review's effectiveness or choose a required interval.
- The field tables describe structural bounds; the mechanics also state cross-field requirements. Malformed input shapes, disallowed keys, and invalid domains cause input errors. Results must remain finite and within the declared output contract. A successful false flag or zero placeholder is distinct from an error.
- Numeric arithmetic uses binary floating point. Exact comparisons have no hidden tolerance or decimal rounding; negative zero is exported as zero. Decimal-text integer operations retain the exactness specifically stated above.
Alternative or Complementary methods
For capa effectiveness review gap, check the source records and the supplied rule before comparing the result with another method. Use a separate evidence or method review when arithmetic consistency alone cannot establish the required conclusion.
References
Similar or alternative tools
- CAPA Review Time Slack
Audit supplied CAPA review clocks without asserting regulatory compliance.
- CAPA Action Due Overdue Day Gap
Calculate capa action due overdue day gap from explicit caller-supplied inputs.