This is a ready-to-use individual training and competency record: the per-person evidence that sits behind a role-based training matrix and proves one person was trained and assessed competent before performing GxP tasks. It is the artifact an investigator asks for when they trace a task back to the person who did it. Replace every <<FILL: ...>> placeholder with your specifics and route it through your training system or document control. A worked filled specimen follows. Verify cited regulations against the current source. This is general guidance to adapt, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Name | <<FILL>> |
| Employee / contractor ID | <<FILL>> |
| Role / job title | <<FILL>> |
| Department / site | <<FILL>> |
| Start date in role | <<FILL: YYYY-MM-DD>> |
| Manager / supervisor | <<FILL>> |
| Record owner | <<FILL: e.g. Training / QA>> |
1. Assigned curriculum and completion
Each item is either read-and-understand (R&U), an assessed competency (AC, requires a test or demonstration), or on-the-job qualification (OJT, requires supervised performance signed off by a qualified assessor).
| # | Curriculum item (SOP / topic) | Doc number | Type | Completed date | Score / result | Trainer / assessor | Refresher due |
|---|---|---|---|---|---|---|---|
| 1 | Good documentation practices | <<FILL>> | R&U | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 2 | Data integrity / ALCOA+ | <<FILL>> | AC | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 3 | Document control | <<FILL>> | R&U | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 4 | Deviation and CAPA | <<FILL>> | AC | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| 5 | <<FILL: role-specific, e.g. protocol execution / audit trail review>> | <<FILL>> | OJT | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
2. On-the-job qualification (for OJT items)
| Task | Supervised performances observed | Assessor confirms competent | Assessor signature | Date |
|---|---|---|---|---|
<<FILL: e.g. execute an OQ test script>> | <<FILL: e.g. 2 observed>> | <<FILL: Yes/No>> | <<FILL>> |
3. Attestation
| Statement | Name | Signature | Date |
|---|---|---|---|
| I have completed the training above and understand it applies to my work | <<FILL: trainee>> | ||
| I confirm this person is trained and assessed competent for the tasks listed | <<FILL: assessor/manager>> | ||
| Reviewed | <<FILL: QA/Training>> |
Field definitions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Curriculum item / doc number | text | Yes | Training/QA | On assignment |
| Type (R&U / AC / OJT) | code | Yes | Training/QA | On assignment |
| Completed date | date | Yes | Trainer | On completion |
| Score / result | text | If AC/OJT | Assessor | On assessment |
| Trainer / assessor | name | Yes | Trainer | On completion |
| Refresher due | date | If applicable | Training/QA | On completion |
Rules
- Training on a task has to be completed and dated before the person performs that task unsupervised; the completion date must predate the first independent performance.
- An assessed competency needs a real result (a score or a demonstrated performance), not just an attendance mark.
- Keep the record current; a training record reconstructed just before an inspection is itself a weakness.
- The person who assesses competency should be qualified to judge it and, for segregation, is not usually the same person being assessed.
Filled specimen
Illustrative, values invented.
| Field | Entry |
|---|---|
| Name | D. Whitfield |
| Role | Validation specialist (entry level) |
| Department | Computer System Validation |
| Start date | 2026-06-01 |
| Manager | S. Iyer |
| # | Curriculum item | Doc | Type | Completed | Result | Assessor | Refresher due |
|---|---|---|---|---|---|---|---|
| 1 | Good documentation practices | SOP-QA-002 | R&U | 2026-06-03 | Acknowledged | S. Iyer | 2028-06-03 |
| 2 | Data integrity / ALCOA+ | SOP-DI-001 | AC | 2026-06-06 | 95% | S. Iyer | 2027-06-06 |
| 3 | Document control | SOP-QA-001 | R&U | 2026-06-04 | Acknowledged | S. Iyer | 2028-06-04 |
| 4 | Deviation and CAPA | SOP-QA-010 | AC | 2026-06-10 | 90% | J. Park (QA) | 2027-06-10 |
| 5 | Execute OQ test scripts | SOP-CSV-004 | OJT | 2026-06-24 | Competent, 2 supervised | S. Iyer | n/a |
On-the-job: D. Whitfield executed two OQ scripts under supervision on 2026-06-20 and 2026-06-24; assessor S. Iyer confirmed competent on 2026-06-24. Only after that date did Whitfield execute an OQ script independently, which is exactly what the delegation and training trail should show. This record, plus the role-based training matrix that assigned the curriculum, is what makes every protocol Whitfield later executes defensible.