This is a ready-to-use go/no-go gate to run before a new analytical instrument, especially a novel one for cell and gene therapy such as a sequencer, ddPCR, flow cytometer, or imager, is used for any GxP work. New instrument software is often built as a scientific tool first and a compliant records system second, so the Part 11 questions must be answered once, deliberately, before the first GMP lot rather than discovered during an inspection. Replace every <<FILL: ...>> placeholder, mark each item Pass / Fail / NA with evidence, and route the completed gate through QA. A filled specimen follows. Verify each cited regulation against the current source. This is general guidance to adapt, not legal or regulatory advice. Pair this with the Log: Instrument Audit Trail and Access Capability Register for the ongoing inventory.
How to use
Each item has a defined pass condition. A Fail is not automatically disqualifying, but it forces a documented compensating control (technical or procedural) that is approved before GMP use, or the instrument does not enter GMP service. Items marked “disqualifying until fixed” cannot be closed by a procedural control alone.
Gate header
| Field | Entry |
|---|---|
| Instrument / system | <<FILL: make, model, software version>> |
| Instrument ID | <<FILL: asset ID>> |
| Intended GxP use | <<FILL: assay / process>> |
| Assessor | <<FILL: name, role>> |
| Date | <<FILL: date>> |
The gate
| # | Item | Pass condition | Result (P/F/NA) | Evidence / compensating control |
|---|---|---|---|---|
| 1 | Original dynamic record | The instrument retains the complete original raw data file with full metadata, re-openable, not only a flattened report | <<FILL>> | <<FILL>> |
| 2 | Audit trail present and on | A secure, computer-generated, time-stamped audit trail of create/modify/delete is on by default and cannot be disabled by users | <<FILL>> | <<FILL>> |
| 3 | Attributability | User actions tie to unique named individuals; no shared logins | <<FILL>> | <<FILL>> |
| 4 | Role-based access | Access is role-based; ordinary users cannot reach administrative functions or delete data | <<FILL>> | <<FILL>> |
| 5 | Clock controlled | The system clock is synchronized and users cannot change it or the time zone | <<FILL>> | <<FILL>> |
| 6 | Readable retention | Records can be retained and read for the full retention period independent of the vendor (open or documented format, proven export) | <<FILL>> | <<FILL>> |
| 7 | No silent deletion | Data cannot be deleted or overwritten without a trace (deletions are audit-trailed). Disqualifying until fixed. | <<FILL>> | <<FILL>> |
| 8 | Reprocessing captured | Any re-analysis, re-gating, or re-integration is recorded with the original retained and visible | <<FILL>> | <<FILL>> |
| 9 | Backup and restore | Data is backed up and a restore has been demonstrated | <<FILL>> | <<FILL>> |
| 10 | Supplier assessment | The software supplier has been assessed for development quality appropriate to the risk | <<FILL>> | <<FILL>> |
Decision
| Field | Entry |
|---|---|
| All items Pass or Fail-with-approved-compensating-control? | <<FILL: Yes / No>> |
| Any disqualifying item open (item 7)? | <<FILL: Yes / No>> |
| Gate decision | <<FILL: Approved for GMP use / Not approved>> |
| QA approval (name, signature, date) | <<FILL>> |
References
21 CFR Part 11 (electronic records and signatures; audit trails, unique accounts, controls). 21 CFR 211.68 (automatic, mechanical, and electronic equipment), 211.194 (laboratory records). EU GMP Annex 11 (computerised systems). FDA guidance, Data Integrity and Compliance With Drug CGMP (2018). FDA guidance, Computer Software Assurance for Production and Quality Management System Software (current version issued 3 February 2026), for the risk-based testing posture. PIC/S PI 041, Good Practices for Data Management and Integrity.
Confirm the current version of each reference before issue.
Filled specimen
Illustrative gate for a newly installed droplet digital PCR system intended for vector-copy release testing. Values are examples.
| # | Item | Result | Evidence / compensating control |
|---|---|---|---|
| 1 | Original dynamic record | Pass | Raw .qlp files retained, re-openable with full metadata |
| 2 | Audit trail present and on | Fail | Audit trail is optional in software; set to on and locked by admin policy; setting verified and documented as a compensating control |
| 3 | Attributability | Pass | Named domain accounts; shared login disabled |
| 4 | Role-based access | Pass | Analyst / supervisor / admin roles configured |
| 5 | Clock controlled | Pass | Time from domain (NTP); “change time” right removed from users |
| 6 | Readable retention | Pass | Export to open CSV plus native format proven; retention path documented |
| 7 | No silent deletion | Pass | Deletions audit-trailed; verified by test |
| 8 | Reprocessing captured | Pass | Re-analysis creates a new versioned result; original retained |
| 9 | Backup and restore | Pass | Nightly backup; restore demonstrated during IQ |
| 10 | Supplier assessment | Pass | Supplier assessment on file, risk rated moderate |
Decision: approved for GMP use, with the item-2 compensating control (audit trail forced on by policy) documented and QA-approved. The one gap, an audit trail that shipped off by default, was closed by configuration and evidence rather than hope, which is exactly what the gate is for.
Common inspection findings this gate prevents
- A just-installed instrument run under a shared generic account because named accounts were never set up.
- An instrument whose audit trail was off because it defaulted off and nobody checked.
- A system where operators can change the clock, breaking contemporaneity.
- Data in a proprietary format that cannot be read once the instrument or vendor is gone.
- Silent deletion or overwriting discovered only after data is lost.
How to adapt this checklist
- Add or remove gate items to match the instrument class and your data integrity procedure.
- For any Fail, write the specific compensating control and get QA approval before GMP use; item 7 cannot be closed procedurally.
- Feed the passed instrument straight into the capability register so the inventory stays current.
- Confirm every regulation against the current published version before issue.