This is a ready-to-use review record, the artifact that proves a second-person review actually happened. A bare initial on a result sheet proves a signature, not a review; this record captures the specific checks so someone who was not there can reconstruct what was examined, by whom, when, and what was found. Replace every <<FILL: ...>> placeholder. Pair it with your review SOP. A filled specimen follows.
Purpose
To evidence that the second-person review of a laboratory result covered accuracy, completeness, and method compliance, explicitly including whether the audit trail was reviewed and whether the sequence reconciled, so the review survives independent retrieval of the same data later.
Header
| Field | Entry |
|---|---|
| Result / sample reviewed | <<FILL: test, sample ID, batch>> |
| Method and system | <<FILL: method ID, instrument / system ID>> |
| Analyst (originator) | <<FILL: name>> |
| Reviewer (second person) | <<FILL: name; must differ from analyst>> |
| Review date | <<FILL: date>> |
Review fields
| Field | Format | Required | Entry |
|---|---|---|---|
| Chromatogram / raw data reviewed | Yes / No + note | Yes | <<FILL>> |
| Integration method matches validated method | Yes / No | Yes | <<FILL>> |
| Manual integrations | Count + all flagged, justified, defensible? | Yes | <<FILL: e.g. 0, or count + justification ref>> |
| Audit trail reviewed | Yes / No + period + finding | Yes | <<FILL: e.g. "Yes, run 2026-06-18; no reprocessing or deletions">> |
| System suitability | Pass/Fail + ran before samples? | Yes | <<FILL>> |
| Sequence completeness | Total injections vs accounted; orphan count | Yes | <<FILL: e.g. 20 of 20 accounted, 0 orphans>> |
| Calculation verified | Yes / No + against what | Yes | <<FILL: e.g. validated LIMS calc>> |
| Result vs specification | Value + spec + pass/fail | Yes | <<FILL>> |
| OOS / OOT / aborts | None, or reference | Yes | <<FILL>> |
| Outcome | Accepted / Returned / Escalated | Yes | <<FILL>> |
| Reviewer signature and date | Signature + date | Yes | <<FILL>> |
Field notes
- Audit trail reviewed and Sequence completeness are the two fields that most often distinguish a real review from a paper one. Neither may be left blank or reduced to “OK”; both take a scope and a finding.
- Manual integrations: if any exist, record how many and reference the manual integration justification for each; a manual integration that crossed a specification limit needs an explicit, strong justification.
- Outcome: “Returned” or “Escalated” is a legitimate and expected outcome; a record that is always “Accepted” invites the question of whether the review has teeth.
Acceptance criteria
- The reviewer differs from the analyst and signs as a uniquely identified individual.
- Every field is completed; the audit trail and sequence fields carry a scope and a finding, not a tick.
- The record was completed before disposition.
- The record lets an independent person reconstruct what was checked and found from the same source data.
Filled specimen
Illustrative completed record. Names and numbers are examples.
| Field | Entry |
|---|---|
| Result / sample reviewed | Assay, sample S-2026-1187, batch B-4402 |
| Method and system | HPLC assay method M-021, CDS instrument HPLC-07 |
| Analyst (originator) | A. Patel |
| Reviewer (second person) | R. Gomez (independent) |
| Review date | 19 June 2026 |
| Chromatogram / raw data reviewed | Yes, opened in CDS (not the PDF) |
| Integration matches validated method | Yes |
| Manual integrations | 0 |
| Audit trail reviewed | Yes, run 2026-06-18; no reprocessing, no deletions, no sample-ID change |
| System suitability | Pass (RSD 0.6 percent, resolution 2.4); ran before samples |
| Sequence completeness | 20 of 20 injections accounted for, 0 orphans |
| Calculation verified | Yes, against validated LIMS calculation |
| Result vs specification | 99.4 percent vs 95.0 to 105.0, pass |
| OOS / OOT / aborts | None |
| Outcome | Accepted |
| Reviewer signature and date | R. Gomez, signed 19 June 2026 |
Because the audit trail field names the run date and the finding, and the sequence field gives the count and zero orphans, this record would still stand if an inspector opened the same run eighteen months later. That is the difference between a control and a signature.
Common findings this record prevents
- A review evidenced only by an initial, proving a signature but none of the checks.
- No field stating whether the audit trail was reviewed, so the review could not have caught reprocessing.
- The sequence never reconciled, so an orphan injection went undetected.
- A manual integration accepted with no reference to its justification.
How to adapt this record
- Add technique-specific fields for the methods your laboratory runs (dissolution vessels, ELISA curve fit, titration blank).
- If you use an electronic review workflow, configure it to require these fields before approval, and capture the reviewer identity and timestamp in the system audit trail.
- Keep the audit trail and sequence fields mandatory in every version.
- Pair it with your second-person review SOP.