Your outcome: Identify the evidence an electronic workflow must preserve and prevent AI-generated text from becoming invented operational evidence.

Know what the system actually controls

Use individual accounts and the approved workflow. Check who can create, change, approve, release and delete records. An audit trail can help reconstruct activity, but it does not automatically prevent an unauthorized change. Configure access, review relevant history and investigate exceptions in proportion to the risk and applicable requirements.

Electronic-signature requirements depend on the record and context. For FDA-regulated records, determine whether the relevant underlying record requirements and 21 CFR Part 11 apply. A signature picture, general e-signature law or a software feature label does not by itself establish a compliant regulated workflow. Obtain the appropriate specialist review when that scope applies.

AI can help prepare a draft

Within an approved tool and data-handling arrangement, AI may help structure an instruction, summarize known feedback or suggest clearer wording. A responsible person must verify the source, facts, technical meaning and required approvals. Keep draft status visible until the authorized review is complete.

AI must not fill in work that did not occur. Do not use it to invent a measurement, inspection result, signature, supplier statement, missing date or release decision. A plausible reconstruction is not an observation. Preserve actual source evidence and label uncertainty.

Review OCR or AI transcription against the original before accepting important quantities, identifiers or decimal values. Protect customer and employee information. Use fictional material for practice and follow the organization's rules before sharing work records with an external service.

Worked example: a missing result

A spreadsheet has an empty inspection cell. An assistant predicts 10.01 mm from neighboring rows. The inspector rejects the prediction as evidence, reports the missing result and follows the authorized process for investigation or inspection. If a new measurement is permitted, it receives its actual date and context; it is not presented as the missing historical observation.

Practice: List one useful AI-assisted drafting task and one task that would fabricate evidence. Identify the reviewer, source record and access limits for the useful task.

Practice check: Complete the two questions attached to this lesson, then review the answer explanations before continuing.