This is the record used to verify a data interface between two systems, the highest data-integrity risk point in automation. It captures the field-by-field mapping with units and transforms, the error-handling and transaction-integrity behavior, and the source-to-target reconciliation. Replace every <<FILL: ...>> placeholder and keep the field definitions with the record. A filled specimen follows. This content is educational and general; adapt it to your own quality system.
Section A: interface identity
Section B: field mapping verification
Verify each mapped field. The transform column is where unit-conversion defects hide.
Section C: error handling and transaction integrity
Section D: reconciliation
Section E: sign-off
References
21 CFR 211.68; 21 CFR Part 11. EU GMP Annex 11 (Computerised systems), including data accuracy checks and electronic data controls. ISPE GAMP 5 (Second Edition, 2022).
Filled specimen
Error test E1 specimen: interface link pulled during transfer; EBR showed a flagged gap and raised alert INT-ALM-07; the defined manual entry fallback was used and reconciled. Pass.
The pressure row is the point of the whole form. Without the divide-by-100 transform the EBR would read 101 instead of 1.01, and a reviewer might not catch it. The explicit transform column makes the conversion testable.
- A unit-conversion or offset defect ships because only the target value was ever reviewed, not the source.
- Interface failure loses data silently, with no gap, alert, or fallback.
- Bi-directional partial writes leave the two systems inconsistent.
- Source and target timestamps drift, so the same event reads as manipulated.
- No reconciliation, so nobody can show the target received everything the source sent.
- List every mapped field, not a sample, in Section B.
- Add the specific failure modes your transport can produce to Section C.
- Define your timestamp tolerance and your peak-load target from real production volumes.
- Reference the parent interface validation protocol and the two systems’ validation records.
- Keep the reconciliation evidence (source and target extracts) as attachments.