Audit Management
Internal Audits · Supplier Audits · Inspection Preparation · Finding Response
Inspection-ready before the auditor walks in — not because of a last-minute scramble, but because your quality system is structured to be that way every day. Replace disconnected checklists, finding logs in spreadsheets, and CAPA responses tracked in email with a single controlled audit program that plans, executes, and closes every audit with a complete and defensible record.
Every audit type in one program
Internal quality audits, supplier audits, mock inspections, accreditation surveys, and management reviews — all running from the same platform, with the same structured workflows, the same finding categories, and the same response requirements.
Findings that flow directly to CAPA
When an audit surfaces a finding that requires corrective action, Kintavo initiates the CAPA from the finding record — pre-populated, linked, and tracked to closure. Nothing gets logged and forgotten between an audit report and a response plan.
An inspection readiness dashboard that runs all year
Open findings, overdue CAPAs, training gaps, and out-of-calibration instruments are visible in one place, all the time — not just in the week before a survey. The organizations that pass inspections cleanly are the ones that audit themselves continuously.
Find the gaps before the inspector does.
Kintavo continuously analyzes your compliance posture — surfacing overdue items, untrained staff, out-of-calibration equipment, and open CAPAs before an inspector identifies them.
Two weeks of binder work — done in minutes.
When an inspection is scheduled, Kintavo generates a pre-audit report covering every compliance domain in scope. What used to take two weeks of manual prep takes minutes.
Plan, execute, close — without the binder marathon.
Whether it's an internal audit, a supplier audit, or a regulatory inspection, the same structured workflow runs the program — and the audit trail is the byproduct.
Plan
Scope, schedule, and assign auditors. Build the checklist by framework.
Prepare
One-click pre-audit report. Audit Intelligence surfaces likely findings.
Execute
Capture observations with severity, evidence, and finding categories.
Respond
CAPAs initiated from findings, linkage maintained automatically.
Close
Verification, sign-offs, and complete report retained for the next cycle.
Audits don't live alone.
Every audit pulls evidence from documents, training, CAPAs, deviations, equipment, and suppliers — built once, retrievable any time.
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 audits can be managed in Kintavo?
Kintavo supports any audit type your quality program requires — internal quality audits, supplier audits, regulatory inspection preparation, accreditation surveys, mock inspections, and management reviews. Each audit type can have its own checklist templates, evidence requirements, finding categories, and response workflows. Most organizations run several audit types simultaneously and manage them all from the same platform.
Q: How does Kintavo help teams prepare for a regulatory inspection?
Kintavo's inspection readiness tools allow quality teams to run structured mock inspections against the same checklists used in real surveys — CAP, TJC, FDA, ISO, and others. Open findings, overdue CAPAs, training gaps, and out-of-calibration instruments are surfaced in a single inspection readiness dashboard before the auditor arrives. Document requests can be fulfilled in minutes rather than hours because every record is controlled, versioned, and linked to the processes it governs.
Q: How are audit findings managed after an inspection?
Every finding logged in Kintavo has a structured response workflow — finding category, severity, root cause, corrective action plan, owner, due date, and effectiveness verification. Findings that require a CAPA can initiate one directly from the audit record, pre-populated with the finding details. Response deadlines are tracked against regulatory or accreditation timeframes. Nothing closes without verification, and the complete response chain is captured in the audit trail.
Q: Can Kintavo manage supplier and vendor audits?
Yes. Supplier audits in Kintavo are linked directly to the vendor record in Supplier Quality. Audit schedules can be configured based on supplier risk tier — high-risk vendors audited annually, lower-risk vendors on a longer cycle. Findings from supplier audits flow into the same finding and CAPA workflows as internal audits. The supplier's audit history, including all findings and responses, is visible on their vendor record alongside qualification status and performance data.
Q: How does Kintavo support audit scheduling and planning?
Audit schedules in Kintavo are built from configurable audit programs — annual internal audit plans, supplier audit cycles, accreditation preparation timelines. Scheduled audits generate advance notifications to audit leads and auditees. Checklist templates are assigned at scheduling time so auditors arrive prepared. Scheduling conflicts, resource availability, and audit frequency requirements are all visible in the audit program calendar.
Q: Can Kintavo generate audit reports automatically?
Yes. When an audit is closed, Kintavo generates a structured audit report from the completed checklist, findings log, observations, and auditor notes. Reports are formatted consistently across all audits of the same type and can be exported for distribution to leadership, regulatory bodies, or accreditation organizations. Historical audit reports are retained on the audit record and searchable by date, audit type, site, or finding category.
Q: How does Audit Management connect to other modules?
Audit records in Kintavo are connected across the platform. Findings can initiate CAPAs directly. Document requests during an audit pull from the controlled document library. Training completion reports are accessible as audit evidence. Equipment calibration status is visible during inspection preparation. Deviation and CAPA records can be surfaced during an audit to demonstrate closure of prior findings. Audit Management is not a standalone tool — it draws on the entire quality system.
Q: Can we track repeat findings across audit cycles?
Yes. Kintavo tracks finding history across all audit cycles, making it straightforward to identify repeat findings — the same process area, the same standard clause, or the same root cause appearing in consecutive audits. Repeat findings are flagged automatically and can trigger an escalated CAPA response. This trending capability is particularly valuable for demonstrating continuous improvement to regulators and accreditation bodies.
Q: Is the audit record 21 CFR Part 11 compliant?
Yes. Every audit action — checklist completion, finding log entry, evidence attachment, corrective action response, closure approval — is captured in a time-stamped, user-attributed audit trail that meets 21 CFR Part 11 and EU Annex 11 requirements. Electronic signatures are required for audit closure and finding response approvals. The complete record of any audit, including all findings and their resolution, is exportable for regulatory submission or accreditation review.
Q: What does implementation look like for Audit Management?
Your implementation lead works with your QA team to configure audit types, checklist templates, finding categories, response workflows, and audit program schedules — typically within the first two to three weeks of onboarding. Historical audit records and open findings can be migrated from spreadsheets or prior systems. Most customers have their first internal audit running in Kintavo within 30 days of kickoff.
Most organizations don't fail inspections because of what they're doing. They fail because of what they can't show.
A finding gets logged in a spreadsheet. A corrective action gets assigned in an email. A follow-up gets missed because the person who owned it left the organization. And when the next inspection cycle comes around, the same finding appears again — because there was no system enforcing that it was actually closed, verified, and couldn't recur.
Kintavo Audit Management gives you a structured audit program where every finding has an owner, a deadline, a corrective action, and a verification step — and nothing closes without evidence. Document requests are fulfilled in minutes because every record is controlled and linked to the process it governs. Your inspection readiness dashboard shows you the state of your quality system in real time, not on the day a surveyor calls to schedule a visit. And when an auditor asks whether a prior finding was resolved, the answer isn't a search through old emails — it's a link to the closed CAPA, the effectiveness check, and the signature that approved it.