This is a ready-to-use checklist for verifying that a receiving site’s automation or control system recipe is genuinely equivalent to the sending site’s before it controls an engineering run. It exists because a batch that completes successfully on a migrated recipe does not prove the recipe is correct; an interlock that silently never triggers, or an alarm threshold sitting an order of magnitude off, will not show up in a functional test of the nominal batch path. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed checklist through your normal document control. A worked filled specimen follows.
Purpose
This checklist confirms, item by item, that a control system recipe or program migrated from the sending site to the receiving site for <<FILL: product / process>> has been independently verified for logical, interlock, alarm, and historian equivalence before it is relied upon for an engineering run or qualification batch.
Scope
Applies to <<FILL: recipe, program, or control system element(s)>> migrated from <<FILL: sending site platform/vendor>> to <<FILL: receiving site platform/vendor>>, whether migrated by direct export/import or manual re-creation.
Checklist
| # | Item | Pass / Fail / NA | Reference / evidence | Verified by | Date |
|---|---|---|---|---|---|
| 1 | Migration method documented (direct export/import vs. manual re-creation) | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 2 | Independent line-by-line logic review completed by someone who did not build the migrated recipe | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 | Every interlock (holds, minimums, maximums, sequencing locks) verified against the sending site’s configuration, value by value | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 4 | Every alarm setpoint and priority verified against the sending site’s configuration | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 5 | Units of measure confirmed consistent at every migrated field (no minutes-for-hours or metric/imperial transposition) | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 6 | Historian / data logging tag mapping verified so migrated data streams map to the correct parameters | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 7 | Dry-run or factory acceptance test executed, deliberately exercising every interlock and alarm condition, not only the nominal batch path | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 8 | Dry-run/FAT predicted vs. actual behavior compared and documented for every exercised condition | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 9 | Any discrepancy found during review or dry-run dispositioned (corrected and re-verified, or documented as an intentional site-specific difference) | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 10 | Verification record filed with the technology transfer documentation before the engineering run | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
Every item must be Pass or a documented, Quality-accepted NA before the migrated automation controls an engineering run. A Fail on any interlock, alarm, or units item holds the recipe from use until corrected and re-verified; a dry-run exercising only the nominal batch path, with interlock and alarm conditions never actually triggered and observed, does not satisfy item 7.
Filled specimen
Extract from an example transfer of Acme Therapeutics’ ATX-207 process to a CDMO running a different automation platform. Company and specifics are illustrative.
| # | Item | Result | Evidence |
|---|---|---|---|
| 1 | Migration method documented | Pass | Manual re-creation documented in TTP-2026-014, section 6 |
| 2 | Independent logic review completed | Pass | Reviewed by automation engineer M. Osei, who did not build the recipe; review record ATN-REV-0087 |
| 3 | Interlocks verified value by value | Fail, then Pass on re-verification | Wash-step hold interlock found entered as 90 hours instead of 90 minutes; corrected and re-verified 2026-09-11 |
| 4 | Alarm setpoints verified | Pass | All 14 alarm setpoints matched sending-site configuration within tolerance |
| 5 | Units of measure confirmed consistent | Fail, then Pass | Same units transposition as item 3, corrected at the same time |
| 6 | Historian tag mapping verified | Pass | 22 of 22 tags mapped correctly, confirmed against sending-site historian export |
| 7 | Dry-run/FAT exercising every interlock and alarm | Pass | FAT-2026-0033 deliberately triggered all 9 interlocks and 14 alarms |
| 8 | Predicted vs. actual compared | Pass | All 23 conditions matched predicted behavior after the item 3/5 correction |
| 9 | Discrepancies dispositioned | Pass | Units transposition corrected and re-verified; no other discrepancies found |
| 10 | Verification record filed | Pass | Filed with TTP-2026-014 before engineering run 1, dated 2026-09-12 |
The specimen shows the checklist doing its job: a real transposition error was caught at item 3 before it reached the floor, corrected, and re-verified, rather than surfacing as an unexplained process hang during the first real batch.
Common findings this checklist prevents
- A migrated recipe verified only by a successful functional run of the normal batch sequence, with interlocks and alarms never actually triggered and observed.
- No independent reviewer; the same person who built the migrated recipe also verified it.
- A units transposition or similar transcription error surfacing for the first time during an engineering run, consuming a scarce batch or starting material lot.
- Historian tag mapping assumed correct with no explicit verification, discovered wrong only when a trend report shows unexpected values.
How to adapt this checklist
- Expand or reduce the item list to match your own control platform’s actual configuration elements, recipes, interlocks, alarms, historian tags, sequencing logic.
- Name the independent reviewer requirement explicitly in your transfer plan so it is not skipped under schedule pressure.
- Design the dry-run or FAT script to deliberately trigger every interlock and alarm condition, not just to run the batch to completion.
- File the completed checklist with the technology transfer documentation before it is needed for an inspection or audit.