Reconstruct
Join records, events, changes and prior cases into a traceable timeline with missing evidence made visible.
Investigation and CAPA
Prepare the case. Protect the conclusion.
The worker reconstructs events, tests competing causes and exposes uncertainty using verified investigation patterns. The authorised investigator owns the conclusion and corrective action.
The question
Can AI support an investigation without making the regulated decision?
01
What is ready for review
02
How gaps and conflicts surface
03
Where professional judgement begins
04
How CAPA remains connected
The operational problem
Most investigations wait on preparation, not on the final call.
01A reviewer cannot assess root cause until records from several systems are complete, the sequence of events is clear and competing explanations have been tested.
02The worker prepares that case and makes uncertainty visible. It does not turn an incomplete evidence set into a confident conclusion.
Investigation path
Keep the same case intact from event to effectiveness review.
The path can be adapted to the organisation’s approved investigation procedure.
Event
Classify the event and initiate required containment.
Evidence
Assemble records, interviews, observations and system events.
Analysis
Build the timeline and test possible causes.
Action
Prepare corrective and preventive actions for approval.
Effectiveness
Collect follow-up evidence and support effectiveness review.
Investigation intelligence
Move from document assembly to disciplined hypothesis testing.
The worker reconstructs the event, checks evidence quality and challenges whether the proposed cause explains the facts. When known patterns fail, it frames the uncertainty for specialist review.
Challenge
Compare plausible causes, seek disconfirming evidence and test whether corrective actions address the mechanism.
Learn under review
Capture the approved resolution as a reusable case pattern and a future evaluation, not an unchecked prompt update.
A closed CAPA becomes more than an archived record. With approval and provenance, it strengthens how later investigations are prepared and tested.
Professional control
The worker assembles and challenges. The investigator concludes.
Important decisions are routed to named roles with the relevant evidence and unresolved questions visible.
Worker responsibility
Deliver a case the investigator can challenge and decide.
Each responsibility is tied to defined evidence rules, procedures and escalation criteria.
Build the evidence set
Collect relevant records and identify missing or conflicting information.
Construct the timeline
Order events, actions and observations with links to their source.
Challenge hypotheses
Compare proposed causes with available evidence and alternative explanations.
Prepare CAPA
Structure actions, owners, due dates and effectiveness criteria for review.
Accountable role
Human judgement and approval
Decisions with material, regulated or professional consequences stay with the named accountable role.
Event classification and containment approval
Acceptance of the evidence set
Root-cause conclusion
CAPA approval
Effectiveness decision
Escalation for material uncertainty
What to measure
Measure whether cases reach review sooner and need less rework.
Define success with the process owner before the worker is configured.
- 01Investigation cycle time
- 02Human review minutes
- 03Evidence completeness
- 04Correction rate
- 05CAPA closure time
- 06Repeat-event rate
Choose a case set
Bring completed cases, including the difficult ones.
A representative case set reveals where evidence is lost, where judgement is needed and which measures matter.