This is a ready-to-use work instruction for the moment a value or a file has to move from one GxP system to another with no validated electronic interface between them, an instrument exporting a CSV into a spreadsheet, a spreadsheet result keyed into a LIMS, a closed platform’s data file copied into a document management system. This kind of manual bridge shows up constantly in cell and gene therapy operations because the system estate is large and integration is often incomplete, and every bridge is a point where a value can be transcribed wrong, truncated, or silently altered. It is task level: the specific checks a person performs, not the policy behind them. Replace every <<FILL: ...>> placeholder, set your document numbers, and route it through document control. A filled specimen follows. Verify each cited regulation against the current source. This is general guidance to adapt, not legal or regulatory advice.
Purpose and scope
This work instruction defines the step-by-step check a person performs whenever data moves between two GxP systems by a manual route, an export and re-import, a copy-paste, a keyed transcription, rather than through a validated electronic interface. It applies to any such bridge feeding a result used for disposition, comparability, or a regulatory submission. It does not replace the qualification of a validated electronic interface where one exists; see the Form: Interface Data Mapping Verification and Reconciliation Record for that case. It also does not replace the review defined in Work Instruction: Vector Copy Number, Potency, and Replication Competent Virus Assay Data Review, which references this instruction for its own transfer step rather than repeating it.
1. Before the transfer
3. Verifying the transfer
4. Field mapping table (attach one per system pair)
5. Handling a discrepancy
- Do not use the destination value. Do not correct it silently to match the source.
- Notify the system owner and Quality Assurance the same working day.
- Determine whether the discrepancy is a one-time transcription error or a systemic format problem (for example, a spreadsheet auto-formatting a date field on every use).
- Open a deviation per
<<FILL: SOP-ID>> where the discrepancy could have affected a result already reported or released.
- For a systemic cause, correct the transfer method (lock the destination field format, change the export template) before the bridge is used again, and document the fix.
Records generated
References
21 CFR 211.68 (automatic, mechanical, and electronic equipment), 211.194 (laboratory records).
21 CFR Part 11 (electronic records; true copies).
EU GMP Annex 11 (computerised systems), including the true copy concept.
FDA guidance, Data Integrity and Compliance With Drug CGMP (2018).
PIC/S PI 041, Good Practices for Data Management and Integrity.
Confirm each reference against the current source before issue.
Filled specimen
An illustrative transfer of a droplet digital PCR vector copy number result from the instrument’s export file into a LIMS worksheet ahead of the potency calculation. Values are examples.
In this example the second-person check caught a spreadsheet auto-rounding a value from three decimal places to two, a difference invisible to a casual glance but capable of shifting a ratio near a specification limit. The transfer was held, the format was fixed at the cause rather than the symptom, and the corrected transfer was re-verified before the potency calculation used it.
Common inspection findings this work instruction prevents
- A CSV export that silently dropped precision, reformatted dates, or truncated rows, discovered only when a downstream result looks wrong.
- No record of who performed a manual transfer, from what source, or when.
- A “verification” that consisted of a glance rather than a value-for-value or checksum check.
- The source file deleted or overwritten once the destination spreadsheet exists, leaving no way to reconstruct the transfer later.
- A systemic formatting problem (an auto-rounding spreadsheet, a locale date-format mismatch) that recurs across many transfers because the one-time fix was never generalized.
How to adapt this work instruction
- Point the parent SOP reference to your actual data governance or data integrity procedure.
- Build one field mapping table (section 4) per system pair in your estate; keep it under document control and update it whenever the export format changes.
- Decide, per system pair, whether checksum verification is feasible (file transfers) or value-for-value comparison is the only option (keyed or summary transfers), and say so in the transfer record.
- Where a system pair transfers frequently, consider whether the manual bridge should instead be replaced with a validated electronic interface; use this work instruction’s discrepancy history as the justification.
- Confirm every regulation against the current published version before issue.
