The trigger
Deviation volume is up. Investigators spend the first hour hunting facts that already exist somewhere: a LIMS flag, an email, a shift note, a previous similar event. A vendor demo showed an assistant producing a complete narrative from a short prompt. Operations wants the time back. Quality has not refused, because the output still goes to a human for approval.
The question in the room is which copilot. The question that is not in the room is which record the investigation will trust next year, and what the reviewer is expected to check versus accept.
Bound the object
One workflow: laboratory deviation from first detection to quality unit approval of the investigation write-up.
Start: an out-of-trend or failing result is noticed.
End: the deviation record in the eQMS is approved.
Out of scope: full CAPA overhaul or laboratory information system replacement.
Intended path vs actual path
Intended path (SOP)
- Analyst or supervisor opens deviation in eQMS upon trigger.
- Immediate actions and product impact recorded directly.
- Investigation gathers facts from LIMS, equipment logs, batch records.
- Root cause and CAPA written into eQMS record.
- Quality unit reviews completeness and approves.
Actual path (Tuesday)
- LIMS event screenshot sent over email.
- Facts accumulate in shared inbox and a Word file (
dev-142-final-v3-USE-THIS.docx). - LIMS result, equipment PDF logs, shift notes remain unlinked in eQMS.
- When Word narrative settles, text is copied into eQMS from memory.
- Quality unit review checks formatting against SOP headings without seeing raw inbox.
Authoritative vs derived records
| Step | What should be authoritative | What people actually trust | Failure if automated as-is |
|---|---|---|---|
| Detection | LIMS event / defined trigger | Screenshot in email | Assistant is fed email screenshots rather than structured data. |
| Immediate action | Timestamped eQMS fields | Memory, then backfilled | Generates a tidy timeline that never occurred in the system. |
| Fact gathering | LIMS, logs, batch records | Pasted text in Word | Source mix is unlogged; hallucinated context mimics real context. |
| Narrative | eQMS investigation record | Word USE-THIS.docx | Assistant drafts into unofficial file; eQMS remains a final dump. |
| Approval | Review against source evidence | Signature on copied text | Approval merely certifies that template headings exist. |
Where a person must stay accountable
- Whether the event is a formal deviation vs note-to-file
- Product impact and batch disposition decisions
- Root cause determination (assistants can cluster language, not own causation)
- Investigation completeness against evidence, not just template headings
- Final Quality Unit approval
Automation boundary
Do not automate in this state: Summarizing unofficial email threads into a formal deviation; drafting from Word with no source list; letting an AI propose root cause.
May be deterministic: Opening eQMS record directly from a LIMS trigger; pulling bounded evidence packs; indexing historical deviations by test code.
Must stay human: Evidence pack completeness sign-off, root cause assignment, quality unit sign-off.
Decision
Clean the process first. Make the eQMS the working file, or state explicitly in writing that it is not. A copilot on top of an unofficial Word file is the wrong kind of success.