Create a compliance checklist

A compliance checklist defines objective confirmations and evidence that must be collected when its scope applies.

Create checklist items that are specific, reviewable, and connected to appropriate evidence.

Before creating the checklist

Identify the requirement, process owner, evidence type, review responsibility, and entities or actions where the checklist should apply. Avoid copying an entire regulation into a single checklist.

Create the checklist

1. Open compliance management and create a checklist.
2. Enter a clear name and purpose.
3. Select the entity type or supported compliance context.
4. Add reference documents or controlled procedures.
5. Create ordered checklist items.
6. Mark which items require evidence.
7. Save the draft and attach it to the appropriate framework or scope.
8. Test it against representative records before activation.

Write effective items

A good item is specific, observable, and reviewable.

Weak: “Confirm the work is compliant.”

Better: “Verify the instrument calibration remains valid through the planned execution date and attach the current calibration certificate.”

Use one requirement per item. State accepted evidence and include a not-applicable path only when organizational procedure permits it.

Evidence

Evidence can include files, photographs, certificates, completed forms, observations, or references to controlled records. Evidence should be legible, attributable, relevant to the exact execution, and retained according to policy.

Scope and authorization

Creating a checklist does not automatically apply it everywhere. Applicability scope determines where it appears. Authorization rules separately determine whether an action is allowed, requires approval, or is blocked.

Review

Periodically review checklist wording, reference documents, scope, completion rates, and recurring failures. Version or replace checklists under change control when requirements change.