Deviation reasoning. CAPA drafting. Change-control thinking.
Investigate·AI sits above your QMS. Reads the deviation, reasons against your evidence, drafts the CAPA, hands the signature to QA. Veeva Vault QMS, MasterControl, ETQ Reliance, Sparta TrackWise Digital - same pattern. We don't replace your QMS. We make it think.
Deviation classification
Severity-tagged at intake. Major / minor / critical per your QMS taxonomy. Linked to product, process, equipment, batch.
Root cause draft
5-Whys, Fishbone (Ishikawa), and FMEA-style reasoning. Multiple hypotheses with evidence weights.
Similar-case retrieval
Vector search across your historical CAPAs. Surfaces precedent and prior root-cause patterns.
CAPA proposal (correction + preventive)
Drafted with evidence chain, owner, due date, effectiveness check criteria.
Change-impact assessment
Feeds Validate·AI: which validated systems, requirements, and test cases are affected by the proposed CAPA.
Audit-defensible reasoning chain
Citable evidence per hypothesis, per ranking, per rejection. Every step in the reasoning trail is queryable.
Bi-directional QMS handoff
Veeva Vault QMS, MasterControl, ETQ Reliance, TrackWise Digital. Signed CAPA writes back; statuses sync.
Effectiveness review
Effectiveness check scheduled and surfaced at the right point in your QMS lifecycle.
Shape Investigate·AI before Q4.
We are accepting six design-partner customers. Co-design the deviation taxonomy, the root-cause reasoning templates, and the QMS handoff. Cohort closes September 30, 2026. Limited to QA leadership at top-50 global life sciences manufacturers.
Six seats. Sixteen weeks. QMS-connector access from day one.
Design partners co-author the deviation taxonomy, root-cause templates, similar-case retrieval model, and the connector spec for Veeva Vault QMS, MasterControl, ETQ Reliance, and TrackWise Digital. Named in the Q4 launch.
Apply to the cohortSix questions cohort applicants ask.
No. The QMS stays your system of record. Investigate·AI sits above it - reasons the deviation, drafts the CAPA, hands the signature to QA, writes the signed record back into your QMS via validated connector.
Your QA reviewer. Always. The agent drafts; QA approves, modifies, or rejects. The signature is human, attributable, 21 CFR Part 11 compliant. The audit trail captures both the agent reasoning and the human decision.
Effectiveness check scheduled at CAPA close with the criteria defined in the draft. Investigate·AI surfaces trending across your CAPA history - recurring root causes, ineffective preventives, patterns by product or process.
The CAPA's proposed change is run against the Validate·AI trace graph. Affected validated systems, requirements, test cases, and SOPs are surfaced - with a revalidation scope proposal. Reviewer-assistive; QA owns the call.
Co-designed during the cohort. Locked at pre-launch rates through 2028. Named-reference customers receive deeper concessions in exchange for joint case-study rights.
Q4 2026 GA. Standard enterprise pricing from there. Cohort customers remain at pre-launch rates with grandfathered terms.