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Can You Prove It? Worksheet
Work through this exercise to verify that every compliance claim you make has traceable, auditable evidence behind it.
The Evidence Test
For every compliance claim your organization makes, ask yourself: can you prove it? Use this worksheet to identify gaps between your stated compliance and your documented evidence.
Step 1: List Your Claims
What compliance claims does your organization make? Common examples:
- "We are ISO 13485 certified"
- "Our products meet FDA requirements"
- "We have full traceability"
- "Our suppliers are qualified"
- "We follow documented procedures"
Step 2: Identify the Evidence
For each claim, what specific evidence supports it?
| Claim | Required Evidence | Location |
|---|---|---|
| ISO Certified | Valid certificate, surveillance audit reports | ___________ |
| Full Traceability | Lot/batch records, device history records | ___________ |
| Qualified Suppliers | Supplier audits, qualification records | ___________ |
| Documented Procedures | SOPs, work instructions, training records | ___________ |
Step 3: Test Retrievability
Can you actually retrieve this evidence? Time yourself:
- < 5 minExcellent — evidence is readily accessible
- 5-30 minAcceptable — may need process improvement
- > 30 minRisk — auditor may question your control
- Cannot findCritical gap — compliance claim unsupported
Step 4: Document the Gaps
For any evidence you cannot quickly retrieve:
- Does the evidence exist but is hard to find?
- Is the evidence incomplete or outdated?
- Does the evidence not exist at all?
- Is the evidence in a format auditors cannot verify?
Close the Evidence Gaps
Structify automatically links your compliance claims to the evidence in your ERP, QMS, and supplier systems — so you can always prove it.
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