This is a ready-to-use form for documenting a manual integration in a chromatography data system. Manual integration is the highest-risk step in analytical data review, because it lets an analyst override the software and, if unchecked, move a result toward passing. The default is automatic integration with the validated method; manual integration is the exception that must be justified, documented, and independently reviewed. Replace every <<FILL: ...>> placeholder. A filled specimen follows.
Purpose
To record the reason for each manual integration, the before-and-after result, the scientific rationale, whether the change crossed a specification limit, and the independent review, so that the integration is defensible rather than convenient and an inspector can reconstruct why it was done.
When to use
Complete one record for every manual integration. Attach or reference it from the analytical data review record. If your procedure prohibits manual integration for a given method, this form is not a route around that prohibition.
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Sample / run ID | Text | Yes | Analyst | At integration |
| Method and system | Method ID, instrument ID | Yes | Analyst | At integration |
| Peak(s) affected | Analyte / peak name | Yes | Analyst | At integration |
| Reason for manual integration | Defined reason, not “improved integration” | Yes | Analyst | At integration |
| Automatic result (before) | Value + units | Yes | Analyst | Before change |
| Manual result (after) | Value + units | Yes | Analyst | After change |
| Scientific rationale | Free text, method-based | Yes | Analyst | At integration |
| Crossed a specification limit? | Yes / No; if Yes, strong justification required | Yes | Analyst | At integration |
| Flagged as manual in the audit trail | Yes / No | Yes | Reviewer | At review |
| Independent reviewer decision | Accept / Reject + basis | Yes | Reviewer | At review |
| Analyst signature and date | Signature + date | Yes | Analyst | At integration |
| Reviewer signature and date | Signature + date | Yes | Reviewer | At review |
The record
| Field | Entry |
|---|---|
| Sample / run ID | <<FILL>> |
| Method and system | <<FILL>> |
| Peak(s) affected | <<FILL>> |
| Reason for manual integration | <<FILL: e.g. split peak from a known shoulder per method note 4.2>> |
| Automatic result (before) | <<FILL>> |
| Manual result (after) | <<FILL>> |
| Scientific rationale | <<FILL>> |
| Crossed a specification limit? | <<FILL: Yes / No>> |
| Flagged as manual in the audit trail | <<FILL: Yes / No>> |
| Independent reviewer decision | <<FILL: Accept / Reject + basis>> |
| Analyst signature and date | <<FILL>> |
| Reviewer signature and date | <<FILL>> |
Acceptance criteria
- The reason is a specific, defined, scientific reason tied to the method, not a vague phrase like “improved integration”.
- Both the automatic (before) and manual (after) results are recorded.
- The integration is flagged as manual in the data system audit trail.
- If the change crossed a specification limit, a strong, independent justification is documented.
- An independent reviewer accepted the integration on a recorded basis.
Filled specimen
Illustrative completed record. Names and numbers are examples.
| Field | Entry |
|---|---|
| Sample / run ID | S-2026-1187, run HPLC-07-2606-014 |
| Method and system | Related substances method M-034, CDS instrument HPLC-07 |
| Peak(s) affected | Impurity D, eluting on the tail of the main peak |
| Reason for manual integration | Valley-to-valley split of a known co-eluting shoulder per method M-034 section 4.2 |
| Automatic result (before) | Impurity D 0.11 percent |
| Manual result (after) | Impurity D 0.12 percent |
| Scientific rationale | Auto-integration dropped the baseline into the main-peak tail; method specifies valley-to-valley for this pair; manual split follows the standard chromatogram |
| Crossed a specification limit? | No (limit 0.20 percent; both values pass) |
| Flagged as manual in the audit trail | Yes |
| Independent reviewer decision | Accept; consistent with the method and the reference standard integration |
| Analyst signature and date | A. Patel, 18 June 2026 |
| Reviewer signature and date | R. Gomez, 19 June 2026 |
This is a defensible manual integration: the reason is method-based, both results are recorded, the change did not cross a limit, it was flagged in the trail, and an independent reviewer confirmed it against the reference standard. The pattern an inspector hunts for is the opposite, a manual integration with a blank or vague reason that nudges a result from just failing to just passing.
Common findings this form prevents
- Manual integration with no recorded reason, or a vague “improved integration” reason.
- A manual integration that moved a result across a specification limit with no strong justification.
- Manual integrations not flagged in the audit trail, so review could not detect them.
- No before-and-after record, so the effect of the manual change cannot be assessed.
How to adapt this form
- Reference the specific method sections that permit valley-to-valley or other manual approaches, so “per the method” points at a real clause.
- Require this form for every manual integration and link it from the second-person review record.
- Trend manual-integration frequency by analyst and method; a rising rate on borderline results is a signal to investigate.