AI root cause investigation software that works with your existing QMS

What the product does

• Investigations of deviations (numbered in the DEV series), OOS or OOT results, complaints, audit or inspection findings and other events, opened from a write-up with the SOP, batch record, lab record, equipment or maintenance log, training record, specification or previous investigation attached.
• Each attached document fingerprinted (SHA-256) and numbered D1, D2…; every quote in the analysis names the write-up or the document it comes from, and a withdrawn document stays on the record with the reason.
• An AI-drafted root cause analysis in seven steps: the problem statement with IS / IS NOT for what, where, when and extent; containment with product and patient impact, other batches and the regulatory assessment; 5 Whys chains with each step marked Evidence or Assumption; a fishbone across six categories; the root cause; the conclusion; and the CAPA plan.
• Every fishbone cause written as a testable hypothesis with a test method and what would support or refute it; the investigator records the result found, the evidence and the outcome, and the cause's disposition (root cause, contributing or ruled out) must agree with the outcome.
• Statistical tests on the data behind a cause: Welch, paired or one-sample t, Mann-Whitney, ANOVA, Fisher's exact or chi-square, with the p-value, effect size and confidence interval recomputed on the server when the test is saved to the record.
• A conclusion judged against eleven checks, among them every hypothesis tested, alternatives excluded, every IS and IS NOT explained, the cause verified and a system cause rather than human error, with a verdict of Robust, Adequate, Weak or Not established that sets how far the root cause confidence can go.
• A CAPA plan of corrections, corrective actions and preventive actions with owners, timing and effectiveness checks, each accepted or rejected by the investigator, who can add their own.
• Each accepted action records where it was raised in your own QMS (the system and the CAPA number); the reference is in the audit trail and on the report, and the panel Hand off to your QMS counts the actions raised.
• A locked PDF report of the approved investigation, with the source and write-up, the analysis, the hypothesis tests, the conclusion and each action with its QMS reference, to attach to the event in your QMS.

How it works beside your QMS

Nothing in the investigation depends on the rest of QLogix. Open it with the event's number in your QMS (the deviation, complaint or OOS number) and the write-up, run the investigation with the AI and the checks, raise the accepted actions as CAPAs in your QMS and record their numbers, then route the investigation for review and approval and attach the approved report to the event. Your QMS keeps the deviation and the CAPAs; QLogix keeps a signed, audited investigation with every quote sourced.

Licensed alone as the Root cause investigation suite (the investigations, document management for your SOPs and the regulatory library), or with CAPA management in the Agentic QMS, where the approved investigation opens a CAPA record prefilled with the root cause and the accepted actions.

How it fits the platform

Investigations open from wherever a problem is found. A complaint routed to investigation starts one with its text, summary and problem statement already written. An out-of-specification result in the LIMS opens an OOS investigation with the result, the determinations, the instruments, the standards and the analyst filled in, linked to the sample both ways, and the result is invalidated only on an assignable cause that investigation found. A CMMS work order that finds a failure opens a deviation investigation with the findings written, an out-of-tolerance calibration opens one with the impact assessment attached, and a deviation on an MES batch names the investigation that handles it.

Where people decide

The AI drafts the problem statement, the 5 Whys, the fishbone and the CAPA plan, reads each hypothesis result and can give a second opinion on the conclusion that changes nothing. The investigator tests each hypothesis, dispositions each cause with a reason, sets the root cause confidence, and accepts or rejects each action; reviewers and approvers sign the investigation with their password. The AI never dispositions a cause, accepts an action or signs.