This is a ready-to-use assessment form for classifying one GxP record stream. Complete one form per stream and attach it to your data governance file. Replace every <<FILL: ...>> placeholder. A worked filled specimen follows. This form supports the SOP: Data Criticality and Data Risk Classification. Verify each cited regulation against the current source before you rely on it.
Field definitions
| Field | Format | Required | Who completes | When |
|---|---|---|---|---|
| Record stream | Text (defined output) | Yes | Process / data owner | At classification |
| System / instrument | Text | Yes | System owner | At classification |
| Generation method | Electronic / hybrid / paper | Yes | System owner | At classification |
| Decision supported | Text | Yes | Process owner | At classification |
| Criticality | High / Medium / Low + rationale | Yes | Owner, QA-reviewed | At classification |
| Inherent risk | High / Medium / Low + rationale | Yes | System owner / SME | At classification |
| Controls present | List | Yes | System owner / IT | At classification |
| Residual likelihood | High / Medium / Low | Yes | SME, QA-reviewed | At classification |
| Priority band | Critical / High / Medium / Low | Yes | Derived | At classification |
| Required control depth | Text | Yes | QA | At classification |
| Owner / approver | Name, date | Yes | Owner and QA | At approval |
| Next review | Trigger + date | Yes | QA | At approval |
Assessment record (blank)
| Field | Entry |
|---|---|
| Record stream | <<FILL>> |
| System / instrument | <<FILL>> |
| Generation method | <<FILL: electronic / hybrid / paper>> |
| Data of record location | <<FILL>> |
| Decision supported | <<FILL>> |
| Criticality (+ rationale) | <<FILL: High/Medium/Low, why>> |
| Inherent risk (+ rationale) | <<FILL: High/Medium/Low, why>> |
| Controls present | <<FILL: logins, RBAC, audit trail + review freq, locked method, transfer, second check, time sync, backup>> |
| Residual likelihood | <<FILL: High/Medium/Low>> |
| Priority band | <<FILL: Critical/High/Medium/Low>> |
| Required control depth | <<FILL: audit-trail review frequency, access model, raw-data retention, validation rigor>> |
| Optional numeric score (C x L) | <<FILL: e.g. 4 x 2 = 8>> |
| Owner (name, date) | <<FILL>> |
| QA approver (name, date) | <<FILL>> |
| Next review (trigger + cycle) | <<FILL>> |
Priority matrix (reference)
| Low residual likelihood | Medium | High | |
|---|---|---|---|
| High criticality | Medium priority | High priority | Critical priority |
| Medium criticality | Low priority | Medium priority | High priority |
| Low criticality | Low priority | Low priority | Medium priority |
Acceptance criteria
- Criticality and residual risk are scored separately, each with a rationale.
- The controls are listed and residual (not inherent) risk drives the band.
- The band maps to a specific, named control depth.
- The owner proposed and QA approved; the form is dated and under change control.
- A review trigger and cycle are set.
References
MHRA GxP Data Integrity Guidance (March 2018); PIC/S PI 041; FDA Data Integrity Q&A (December 2018); EU GMP Annex 11; 21 CFR Part 11; ICH Q9.
Confirm the current version before you rely on it.
Retention
Retain with the data governance records for not less than <<FILL: retention period>>.
Filled specimen
Two completed rows on the same dial, so the contrast is visible. Illustrative.
| Field | Stream A | Stream B |
|---|---|---|
| Record stream | Finished-product HPLC assay (release) | Dispensing balance weighment |
| System / instrument | Chromatography data system | Calibrated balance + paper ticket |
| Generation method | Electronic, auto-transfer to LIMS | Hybrid: print, transcribe, verify |
| Decision supported | Batch disposition / CoA | Batch formulation |
| Criticality | High (drives release) | High (wrong weight, wrong dose) |
| Inherent risk | High (configurable, manipulable) | Medium-High (transcription, ticket can be reprinted) |
| Controls present | Logins, segregated admin, locked method, audit trail reviewed per run, time sync, LIMS | Ticket retained as raw data, contemporaneous second-person verification, ticket attached to batch record |
| Residual likelihood | Low-Medium | Low-Medium |
| Priority band | Critical / High | High |
| Required control depth | 100% audit-trail review per release run; controlled reprocessing; periodic DI self-audit | Retain printout as raw data; second-person verification; missing/reprinted ticket is a deviation; no audit-trail review (no audit trail exists) |
| Numeric score (C x L) | 4 x 3 = 12 | 4 x 2 = 8 |
| Owner / QA | Lab system owner / QA, dated | Production / QA, dated |
| Next review | Annual or on CDS change | Annual or on process change |
Both streams are high-criticality, but they need different controls: the CDS needs audit-trail review because its risk is electronic manipulation, while the balance needs raw-data retention and a second check because its risk is transcription. The form makes that reasoning explicit and approvable.
Common inspection findings this form prevents
- A final score with no rationale, so the classification cannot be defended.
- Inherent risk recorded but the controls and residual conclusion missing.
- A priority band that maps to nothing concrete.
- No QA approval or no review trigger, so the classification is treated as no classification.
How to adapt this form
- Complete one form per record stream from your inventory.
- Score criticality and residual risk separately, each with a rationale.
- List the controls and map the band to a named control depth.
- Have the owner propose and QA approve, date it, and set the review trigger.