Transcript
Start with the required record
Part 11 applicability is not decided by asking whether software has an audit trail. First identify the record required by an applicable predicate rule. Then determine whether the organization creates, modifies, maintains, archives, retrieves, or transmits that record electronically and relies on the electronic form for regulated activity.
Understand signatures and record meaning
If electronic signatures are used, define the signer, signature meaning, record association, timing, identity control, and prevention of repudiation or misuse. For records, assess access, accurate and complete copies, retention, audit history, operational checks, authority checks, and the configured workflow that preserves meaning.
Apply controls to actual use
Document the applicability conclusion for each important record or signature use, including exclusions and uncertainty. Use the current regulation, applicable FDA guidance, predicate requirements, and approved procedures. A feature checklist can help after scope is known, but it cannot replace the record-specific assessment.