This is a ready-to-use record for a single-result end-to-end data-integrity trace: pick one release-critical result and follow it backward through every system it touched, the way an inspector will. Run it as a self-audit before an inspection, or as evidence during one. Replace every <<FILL: ...>> placeholder and complete each step honestly; a broken link you find first is a finding you can fix. A filled specimen for a ddPCR titer follows. Verify each cited regulation against the current source. Pair with the Checklist: Advanced Therapy Data Integrity Readiness.
Record header
| Field | Entry |
|---|---|
| Trace record number | <<FILL: TRACE-YYYY-nnn>> |
| Date / performed by | <<FILL>> |
| Product / lot or study | <<FILL>> |
| Result traced | <<FILL: e.g. VG titer, potency, identity value>> |
| Reported value / where | <<FILL: value; BLA table / CoA / LIMS record>> |
| Reason for trace | Pre-inspection self-audit / Inspection response / Periodic |
Step 1: Start at the reported result
| Field | Entry |
|---|---|
| Reported value and units | <<FILL>> |
| Specification and pass/fail | <<FILL>> |
| Disposition record citing it | <<FILL: batch disposition / release reference>> |
| Does the release decision cite this exact number? | Yes / No: <<FILL>> |
Step 2: The transfer into the system of record
| Field | Entry |
|---|---|
| Source software to LIMS/report path | <<FILL>> |
| Transfer method | Verified interface / Checksum / Manual retype |
| Transfer logged on both sides? | Yes / No |
| Value matches source exactly? | Yes / No: <<FILL>> |
Step 3: The analysis that produced the number
| Field | Entry |
|---|---|
| Instrument / software / version | <<FILL>> |
| Analysis parameters (threshold, gating, integration) captured? | Yes / No |
| Any parameter changed? Reason and attributable user recorded? | <<FILL: or N/A>> |
| Analysis template versioned and controlled? | Yes / No |
Step 4: The audit trail around the analysis
| Field | Entry |
|---|---|
| Audit trail reviewed for this run | Yes / No |
| Acquisitions performed (count) | <<FILL>> |
| Reported results (count) | <<FILL>> |
| Difference accounted for with documented justification? | Yes / No: <<FILL>> |
| Every change carries old value, new value, who, when, why? | Yes / No |
Step 5: The raw data
| Field | Entry |
|---|---|
| Raw acquisition still exists? | Yes / No |
| Retained in dynamic form (not flattened PDF)? | Yes / No |
| Reconstructable to the reported result? | Yes / No |
Step 6: Second-person review and clock
| Field | Entry |
|---|---|
| Documented second-person review before disposition? | Yes / No |
| Timestamps from a synchronized, protected clock? | Yes / No |
| Any result invalidated? Approved OOS/atypical justification on file? | <<FILL: or N/A>> |
Findings and routing
| Step | Link status (intact / broken) | Gap description | Route (CAPA / deviation / remediation) |
|---|---|---|---|
| 1 Disposition | <<FILL>> | <<FILL>> | <<FILL>> |
| 2 Transfer | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 Analysis | <<FILL>> | <<FILL>> | <<FILL>> |
| 4 Audit trail | <<FILL>> | <<FILL>> | <<FILL>> |
| 5 Raw data | <<FILL>> | <<FILL>> | <<FILL>> |
| 6 Review/clock | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every acquisition the instrument performed is accounted for, reported or explained.
- Each analysis parameter and any change appears in the audit trail with a reason and an attributable user.
- The reported value matches the instrument value, with the transfer verified, not retyped.
- A documented second-person review preceded disposition.
- The raw data still exists in dynamic form and reconstructs the reported result.
- No result was invalidated without an approved justification.
Sign-off
| Field | Entry |
|---|---|
| Performed by (name, signature, date) | <<FILL>> |
| QA reviewed (name, signature, date) | <<FILL>> |
| Overall: fully reconstructable? | Yes / No; if No, remediation reference: <<FILL>> |
References
21 CFR 211.194 (complete laboratory records), 211.192 (discrepancy investigation), Part 11.10(e) (audit trail). FDA Data Integrity and Compliance With Drug CGMP Q&A (final, Dec 2018). FDA OOS guidance (Rev. 1, May 2022) for retained data and justified invalidation.
Confirm each reference against the current source before issue.
Filled specimen: vector genome titer by ddPCR
| Step | Entry |
|---|---|
| Result traced | VG titer 4.2e12 vg/mL, lot AAV-26-0142, reported to LIMS and CoA |
| 1 Disposition | Release record R-26-0142 cites 4.2e12; matches. Intact |
| 2 Transfer | Instrument software to LIMS via validated interface IFC-07; logged both sides; matches. Intact |
| 3 Analysis | ddPCR software v<<FILL>>; amplitude threshold set 3200 then edited to 3450 with reason “negative cluster overlap, per SOP 7.4”, attributable to a.morgan; template versioned. Intact |
| 4 Audit trail | 1 acquisition, 1 reported result; one threshold change with reason; reconciles. Intact |
| 5 Raw data | .ddpcr file retained in dynamic form; reconstructs 4.2e12. Intact |
| 6 Review/clock | Second-person review by r.singh before disposition; clock synchronized. Intact |
| Overall | Fully reconstructable; no remediation needed |
The failure version of this same trace usually breaks at Step 4 or Step 5: three acquisitions with only one reported result and no justification for the other two, or the borderline first analysis overwritten. Finding that yourself, first, is the entire point of running the trace before an inspector does.
How to adapt this form
- Run it on at least one release-critical result per period and before any inspection.
- Adapt Step 3’s parameters to the modality: gating for flow cytometry, pipeline parameters for sequencing, curve fitting for potency, integration for chromatography.
- Route every broken link to CAPA or the DI remediation program before the real inspection.
- Confirm each reference against the current source before use.