Deviation Management
Quality Events · Investigations · Impact Assessments · CAPAs
Every quality event captured, investigated, and closed — with nothing falling through the cracks. Replace scattered email threads and manual logs with structured workflows that enforce completeness, route automatically, and hand off to CAPA without a gap in the record.
Enforced Completeness
Every deviation has required fields, mandatory evidence, and a structured investigation — staff can't close a record without finishing the steps that make it defensible.
Connected to the Quality System
A deviation in Kintavo knows what product, equipment, and procedure it touched — and automatically initiates the CAPA when the investigation warrants it.
AI that surfaces patterns
Kintavo AI flags recurring deviation types, identifies root cause trends across your records, and drafts investigation summaries from structured inputs.
A deviation can't close without finishing the steps.
Incomplete deviation records are one of the most consistent FDA inspection findings. In Kintavo, the structure is the process — staff cannot work around it.
From capture to closure — with the audit trail built in.
Every deviation moves through the same structured workflow, regardless of who initiates it or where in the organization it surfaced.
Capture
Structured initiation with type, severity, and immediate routing.
Triage
Severity classification with different handling by level.
Investigate
Required fields, evidence attachment, enforced completion.
Assess
Impact on product, process, and prior records documented.
Resolve
CAPA initiated if needed. Closure requires verification.
Every deviation surfaces where it matters.
A deviation in Kintavo knows what product it affected, what equipment was involved, what procedures were in use, what CAPA was initiated, and how it resolved — in one record.
Deviations don't live alone.
Every deviation links to the equipment it involved, the procedures in use, the CAPA it triggered, and the documents that change because of it.
Ready to see the full platform working for your organization?
Book a personalized demo. We'll show you Kintavo configured for your regulatory environment and your specific workflows — not a generic product tour.
FAQ Questions & Answers
Q: What types of quality events can be logged as deviations in Kintavo?
Kintavo supports any event type your organization defines — out-of-specification results, process deviations, product nonconformances, equipment failures, documentation errors, environmental excursions, and clinical incidents. Each deviation type can have its own required fields, severity tiers, routing rules, and workflow steps, so the form staff see matches the event they're reporting.
Q: How does Kintavo enforce that a deviation is actually completed before it's closed?
Closure is gated by workflow completion, not just a status change. Required fields, evidence attachments, investigation documentation, impact assessment, and CAPA initiation (when triggered) must all be completed before the system allows a record to move to closed. Approvers see exactly what's missing before they sign. This is configurable by deviation category and severity level, so a minor process deviation and a major product nonconformance can have different closure requirements.
Q: Can production and lab staff initiate deviations, or is it only QA?
Any user with the appropriate role can initiate a deviation — production operators, lab technicians, clinical staff, or QA. The initiation form is simplified for non-QA users: they capture the essential event details and Kintavo routes it to the right QA owner automatically based on event type, site, and severity. QA retains control of investigation and closure steps.
Q: How does severity classification work?
Kintavo supports configurable severity tiers — typically Critical, Major, and Minor — with different handling rules for each. Critical events can trigger immediate notifications, mandatory escalation paths, and shorter response time targets. Major events require full root cause investigation and impact assessment. Minor events can follow an abbreviated workflow. Your QA team defines the tiers and the rules; Kintavo enforces them.
Q: How does Deviation Management connect to CAPA?
When an investigation concludes that a corrective or preventive action is warranted, Kintavo initiates a CAPA record directly from the deviation — pre-populated with the event details, root cause findings, and linked evidence. The deviation and CAPA records remain linked, so auditors can trace from the initial event all the way through corrective action closure and effectiveness verification in one chain without hunting across systems.
Q: Can I link a deviation to specific products, batches, equipment, or documents?
Yes. Deviations in Kintavo are cross-referenced to any other record in the system — lot numbers, equipment assets, SOPs in use at the time, supplier records, audit findings, or prior related deviations. This linkage makes impact assessment faster and gives auditors a complete picture of what was affected without manual reconstruction.
Q: Does Kintavo support trending and signal detection across deviation records?
Yes. Kintavo's AI continuously monitors open and closed deviation records for recurring patterns — the same root cause appearing across different sites, the same equipment appearing in multiple events, deviation rates trending upward in a specific process area. Quality leaders see trending signals in the dashboard before they escalate to a systemic finding, and the AI can draft a trend summary for management review or inspection readiness.
Q: Is the deviation record 21 CFR Part 11 compliant?
Yes. Every action taken on a deviation record — initiation, investigation updates, approvals, CAPA linkage, closure — is captured in a time-stamped, user-attributed audit trail that meets 21 CFR Part 11 and EU Annex 11 requirements. Electronic signatures are used for approval and closure steps. The audit trail is immutable and exportable for inspection purposes.
Q: What does implementation look like for Deviation Management specifically?
Your dedicated implementation lead configures deviation types, severity tiers, required fields, routing rules, and workflow steps with your QA team — typically in the first two to three weeks of the engagement. You don't need IT involvement to configure the workflows; your quality team drives it through Kintavo's no-code workflow builder. Most customers are processing live deviations within 30 days of kickoff.
Q: Can we migrate existing open deviations from our current system?
Yes. Kintavo's migration toolkit supports import of open and historical deviation records from spreadsheets, legacy QMS platforms, or exported data from other systems. Historical records are preserved for trending and audit continuity. Your implementation lead will scope the migration as part of the onboarding plan.
Your quality events are being tracked in places that can't actually close them.
Spreadsheets don't enforce an investigation. Shared inboxes lose the evidence attachment. Paper logs make impact assessment a manual reconstruction project. When an inspector asks to see every deviation from the last 12 months — with root cause documentation, impact assessments, linked CAPAs, and closure approvals — most quality teams spend days pulling it together from three different systems and hoping nothing got missed.
Kintavo Deviation Management gives you a single structured environment for every quality event from first report to verified closure. Workflows that enforce completion before anything closes. Investigations that cannot be skipped. CAPA initiation that happens automatically when the record warrants it.