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Form Plug-and-play starting point Manufacturing Automation

Form: Interface Data Mapping Verification and Reconciliation Record

A plug-and-play record for validating a data interface between automation systems (DCS to MES/EBR, historian to LIMS): source-to-target field mapping with units and transforms, error handling, transaction integrity, reconciliation, and sign-off, with field definitions and a filled specimen.

Document type: Form

Read and copy the template below into your own quality system. It is a generic starting point for your own internal use, provided as is, with no warranty; see the Terms and License. Adopting it does not by itself create compliance.

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

FieldEntryDefinition
Interface ID<<FILL>>Unique identifier
Source system<<FILL: e.g. DCS FERM01>>Where the data originates
Target system<<FILL: e.g. MES/EBR>>Where the data lands
DirectionOne-way / Bi-directionalBi-directional needs transaction-integrity testing
Transport<<FILL: API / file drop / middleware>>The mechanism
GMP impact<<FILL>>Does the target field feed the batch record

Section B: field mapping verification

Verify each mapped field. The transform column is where unit-conversion defects hide.

#Source fieldTarget fieldSource unitTarget unitTransform / roundingTest inputExpectedActualP/F
1<<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>>
2<<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>>
3<<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>><<FILL>>

Section C: error handling and transaction integrity

#TestExpected behaviorActualP/F
E1Interface fails mid-transferTarget shows a gap or raises an alert; defined manual fallback invoked, no silent loss
E2Bi-directional partial writeAll-or-nothing, or a documented reconciliation step; no inconsistent state
E3Out-of-sequence or duplicate messageHandled per design; no corrupted or duplicated record
E4Peak transaction loadNo dropped or delayed records beyond the defined limit
E5Timestamp alignmentSource and target timestamps consistent within the defined tolerance

Section D: reconciliation

FieldEntry
Records sent by source (period)<<FILL>>
Records received by target<<FILL>>
Discrepancy<<FILL>>
Each discrepancy explained<<FILL: Yes, with detail / No>>

Section E: sign-off

RoleNameSignatureDate
Executor<<FILL>>
Process SME<<FILL>>
QA<<FILL>>

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

#Source fieldTarget fieldSource unitTarget unitTransformTest inputExpectedActualP/F
1FERM01.TEMPStep3.TemperatureCCnone, 1 dp37.037.037.0Pass
2FERM01.PHStep3.pHpHpHnone, 2 dp7.057.057.05Pass
3FERM01.PRESSStep3.PressurekPabardivide by 1001011.011.01Pass

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.

Common inspection findings this form prevents

  • 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.

How to adapt this form

  1. List every mapped field, not a sample, in Section B.
  2. Add the specific failure modes your transport can produce to Section C.
  3. Define your timestamp tolerance and your peak-load target from real production volumes.
  4. Reference the parent interface validation protocol and the two systems’ validation records.
  5. Keep the reconciliation evidence (source and target extracts) as attachments.
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