Regulatory News

Where Did This Field Come From?

Pick any field in a safety case, the onset date, the reaction term, the dose, and an inspector can ask the same thing: where did this come from? When a case processor types it in, the answer is a person, a source document and a date. When AI drafts the field, the answer has two parts, and both need to be on record.

ALCOA Still Applies

ALCOA is the data integrity test regulators have used for years across GxP: data should be attributable, legible, contemporaneous, original and accurate. The extended version, ALCOA+, adds complete, consistent, enduring and available. When a model drafts the data, each principle needs a different kind of evidence.

What It Means for an AI-Drafted Field

Attributable. The record should show the system that proposed the value and the named reviewer who accepted, changed or rejected it. If the trail shows only the reviewer, nobody can see how the value got there. If it shows only the system, nobody is accountable for it.

Legible. An inspector should be able to follow the reasoning from the exported record, without needing a demo of the tool.

Contemporaneous. The record has a time stamp for when the field was drafted and another for when it was reviewed.

Original. The source document stays as it arrived. Extracted text, translations and OCR output are copies, and should be marked as such.

Accurate. Every value can be checked against the exact passage it came from, and any edit the reviewer makes is logged with what it was before.

Questions to Ask Before a Pilot

If you are evaluating AI for case processing or literature screening, ask the vendor these five questions:

  • Can I go from any field to the exact text in the source that supports it?
  • Does the audit trail separate what the system proposed from what the reviewer decided?
  • Is the original document stored unchanged, alongside any extracted or translated text?
  • Are reviewer edits logged with the previous value, who changed it and when?
  • Can all of this be exported for an inspection without access to the tool?

How We Approach It

We built Vigintake around that first question. Every field a reviewer sees points to the line in the source it came from, and every draft, edit and approval stays in the record. The system prepares the case, the reviewer decides, and the audit trail records both. We validated the whole system under GAMP 5, including the audit trail.

If you want to see what that trail looks like on your own cases, get in touch.