Audit Management Software Built for Regulated Industries
Plan, execute, and close audits with ISO 19011-aligned workflows, structured findings, and corrective actions linked directly to training.
The Audit Management Problem: Book a Demo
An audit gets completed. Findings get recorded. CAPAs get assigned. But when an inspector asks for the full story — from finding to corrective action to verified closure — no one can pull it together without assembling records from three different places.
- ❌ Audit findings are tracked in spreadsheets disconnected from corrective action systems
- ❌ CAPA responses are managed separately from the findings that generated them
- ❌ Training gaps identified in audits don’t automatically trigger workforce training assignments
- ❌ Follow-up audits lose the thread — no link back to the original findings and actions
- ❌ Audit scores and trends require manual assembly at management review time
The eLeaP Solution:
eLeaP gives quality teams one place to plan, execute, and close every audit — internal quality audits, supplier qualification audits, GMP compliance audits, and more. Every finding links to a corrective action. Every corrective action links to a verified outcome. When an audit identifies a training gap, the LMS is one click away.
- ✅ Full audit lifecycle per ISO 9001:2015 and ISO 19011:2018 — planning through verified closure
- ✅ Structured findings with classification, scoring, root cause, and immediate action fields
- ✅ CAPA linked directly to findings — traceable from observation to resolution
- ✅ Audit-level risk tracking using the ISO 14971 P1×P2 probability model
- ✅ Inspection-ready audit report export with full findings, team, meetings, and CAPA records
Start your free 30-day trial. No credit card required. Or schedule a demo to see it in your environment.
One System for Every Audit Type
eLeaP Audit Management handles internal process audits, supplier qualification audits, GMP compliance audits, document control reviews, and system audits — each following a structured workflow with phase-based documentation, scored findings, and integrated corrective actions. When an audit is closed, the audit trail is complete. When a training gap is identified, the LMS is one click away.
At the core of eLeaP QMS is an audit module designed for regulated industries — a single system where every audit, regardless of type, follows a structured lifecycle from scope definition through findings, corrective actions, and verified closure. Built-in risk tracking, ISO 19011-aligned team roles, formal meeting documentation, and AI-generated audit templates mean nothing falls through the cracks and every decision is documented.
Key Features
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Full Lifecycle Planning
Define audit scope, objectives, applicable regulatory standards, and the risk-based rationale for selecting each audit area. Document pre-audit document request lists and assign team roles before the audit begins.
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Structured Findings With Scoring
Capture findings with classification (Major NC, Minor NC, Observation, OFI), Pass/Fail/N/A scoring, immediate containment actions, root cause, responsible owner, and response deadline. Audit score calculates automatically.
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Integrated CAPA Linkage
Link corrective actions directly to findings for full ISO 9001 traceability. Track each CAPA from Open through In Progress, Implemented, and Verified — with evidence attached at the finding level.
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ISO 19011-Aligned Team Management
Assign Lead Auditors, Auditors, and Technical Experts. Declare and document conflicts of interest at the team member level per ISO 19011:2018 §5.4.
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Formal Meeting Documentation
Record opening and closing meetings per ISO 19011:2018 §6.4 — including agenda, attendees, discussion notes, and agreed observations. Full meeting records export with the audit report.
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Audit-Level Risk Tracking
Add risks linked to the eLeaP Risk Management module. Risk scores calculate automatically using the ISO 14971 P1×P2 probability model, consistent with your other risk records.
Why Select eLeaP Quality?
eLeaP Audit Management is built for regulated industries — pharmaceutical, medical device, biotech, aerospace, automotive, and general manufacturing. When an audit finding generates a CAPA that identifies a training gap, the LMS is one click away. When a finding requires a document revision, Change Control is already connected. One audit. One traceable record. One system.
The Closed-Loop Difference
eLeaP is the only QMS with an enterprise LMS built in. When an audit finding generates a CAPA that identifies a training gap, the corrective action triggers a targeted training assignment in the eLeaP LMS — automatically. Training completion records link back to the originating finding, giving you documented evidence that the corrective action included verified workforce competency.
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Every audit. One structured workflow. Nothing assembled manually.
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Identify repeat findings before they become inspection observations.
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Complete audit trail from scope definition to verified CAPA closure.
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When an audit identifies a training gap, the LMS is one click away.
Proven Benefits:
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Complete Traceability
Every finding links to a corrective action. Every corrective action links to a verified outcome. Every outcome links back to the finding that triggered it. Full traceability in a single audit record.
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Fewer Repeat Findings
Root cause fields on every finding, combined with CAPA tracking and follow-up audit linking, create the structure needed to address issues at the source — not just document them.
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Inspection-Ready at Any Time
Every decision, every team assignment, every approval, every corrective action is documented in a complete audit trail. When an inspector asks, you pull it up — you don’t assemble it.
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Risk-Based Audit Planning
Pre-audit risk rationale fields and audit-level ISO 14971 risk tracking bring the ISO 19011:2018 risk-based approach requirement into the audit record itself.
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Faster Audit Closure
Structured workflows, assigned owners, response deadlines, and automatic status tracking move audits from planning through verified CAPA closure without manual follow-up holding up the process.
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Training Gap Closure
When an audit identifies a training gap, the connected LMS assigns targeted training automatically. Completion records link back to the finding. No standalone QMS can demonstrate this.
eLeaP Audit Management is trusted by organizations across pharmaceutical, medical device, biotech, manufacturing, and aerospace industries to keep audit findings from becoming repeat observations. Start your free trial below or schedule a demo today. Start your free trial below or schedule a demo today.
The Audit Management Module is part of the comprehensive eLeaP Quality Management System.