CAPA software for GMP manufacturing: deviation investigations, root cause analysis and effectiveness checks

What the module 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(SHA-256) and numbered D1, D2…; every quote in the analysis names the write-up or the document it comes from, and a withdrawn document stays on the record with the reason.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.
• CAPA records opened from the approved investigation with the problem statement, root cause, classification and accepted actions carried in; an AI review of the plan for adequacy, gaps and extent of condition; plan approval refused while retraining is the only corrective or preventive action.
• Actions completed with evidence, an effectiveness check against the method and criterion defined in the plan, and closure as Effective: close or Not effective: escalate, with the follow-up CAPA or investigation opened.

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.

After approval, the investigation opens the CAPA record or raises a change control, and the CAPA's stage (plan, plan approved, implementing, effectiveness check, closed) is derived from what the record contains. A change control whose effectiveness is not met cannot close until a CAPA is raised and linked. Backlog triage ranks the open deviations and CAPAs by risk, the work queue shows what each record is waiting for, and built-in alerts flag an investigation open past its target and CAPA actions not yet decided.

Where people decide

The AI drafts the problem statement, the 5 Whys, the fishbone and the CAPA plan, reviews the plan for adequacy 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. The CAPA owner records the evidence for each action and the effectiveness result, and the closure is signed. The AI never dispositions a cause, closes a record or signs.