Find the evidence gaps before an audit does.
Ten questions on the evidence auditors commonly ask for. Your answers give a list of areas to look at — a self-check, not a compliance assessment or a prediction.
Ask the questions an auditor asks, and look for the evidence yourself.
Pick an area, read where the evidence usually sits in V5 records, then rate what your team can actually show. The example answers come from the same fictional product. Fictional example: invented names and values, not customer data or a product screenshot.
Can you show who signed a record, when and what the signature meant?
- Where it sits
- Electronic signatures on the record, with printed name, date and time, and meaning.
- Example
- Test A result on S-0142-01: signed by Analyst B, 6 Oct 2026, 11:20, meaning 'Reviewed'.
0 of 6 rated
- Evidence found
- 0
- Partly
- 0
- Not found
- 0
No gaps rated yet. Your quality team decides what counts as enough.
Conceptual illustration · fictional example
A self-check your team runs and owns. V5 does not score compliance or certify anything; your quality team decides what is enough for your regulations and intended use. Which records, fields, sign-offs and rules apply follows your procedures, workspace configuration and user permissions.
Audit evidence you can find, not rebuild.
A comparison of how the work is done, not a measured result.
UltimateFree guide
Audit Evidence Readiness Checklist
Audit Evidence Readiness Checklist
Ask yourself the questions auditors commonly ask, find the records that answer them, and turn every gap into an action with an owner.
- Six evidence questions
- Where to look for each
- Worked self-check example
- Gap and action log
How are production records captured today?
Can you show who signed a record, when, and what the signature meant?
Can you show what changed on a record, the earlier value, who and when?
Can you show who was trained on the procedure revision in force?
Can you show which procedure revision was in force on a given day?
How is a deviation recorded when it happens?
Can you trace a lot forwards and backwards when asked?
Can you show an instrument was within its calibration interval when used?
Can you show how a procedure or specification change was approved and made effective?
Do you have current validation evidence for your quality systems' intended use?
Answer all 10 questions to see the areas to look at (0/10 done).