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 is 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 are tracked apart from the workforce training records
- ❌ 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 audits, GMP compliance audits, and more. Every finding links to a corrective action. Every corrective action links to a recorded outcome. When an audit identifies a training gap, you can link the corrective action directly to the training record in the LMS.
- ✅ Full audit lifecycle aligned to 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
- ✅ Opening and closing meeting records, audit team roles, and conflict-of-interest declarations in the audit record
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
The eLeaP Audit Management System handles internal process audits, supplier 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.
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. Checklist templates, risk tracking, ISO 19011-aligned team roles, and formal meeting documentation keep every decision in one record. Audits are part of the Events module, alongside deviations, nonconformances, and CAPAs.
Key Features
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Planning with Scope and Templates
Create an audit with its type (such as On-site, Remote, or Periodic Review), owner, due date, and a form template that drives its phases. Define the scope: processes covered, locations, applicable clauses or standards, and formal exclusions. Administrators can generate audit templates with AI and refine them.
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Structured Findings With Scoring
Capture findings with classification (Major NC, Minor NC, Observation, Opportunity for Improvement), Pass/Fail/N/A scoring, clause reference, process, immediate action, root cause, responsible owner, and response deadline. Each finding moves from Open through In Progress and Closed to Verified, and the audit score calculates automatically.
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Integrated CAPA Linkage
Add corrective actions directly to a finding, or link an existing event (CAPA) already in the system. Track each action from Open through In Progress and Implemented to Verified, with effectiveness notes and evidence.
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ISO 19011-Aligned Team Management
Assign a Lead Auditor, Auditors, Technical Experts, and other members, and declare and document conflicts of interest at the team member level. Each person appears once on the team, with a visible badge where a conflict is declared.
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Formal Meeting Documentation
Record opening and closing meetings per ISO 19011:2018 §6.4, including numbered agenda items, attendees with role and department, discussion notes, and agreed observations. Attach supporting files to each record.
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Audit-Level Risk Tracking
Link risk items from the Risk module to the audit for risk-based auditing. Each linked risk shows its approval status, probability and severity, and calculated risk level, consistent with your other risk records.
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Phases and Follow-Up Audits
Template-based audits show phases such as preparation, clause review, findings summary, and conclusion, each with its own owner, status, and data entry form. Marking a phase done validates required fields first. Follow-up audits link back to their parent audit with a visible badge.
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Supplier Audits
Schedule supplier audits manually from the supplier record, or let supplier policies generate recurring audits by supplier type and risk level, with the next audit date shown on the supplier list.
What You Get with eLeaP Audit Management
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Automatic Status and Score
Audit status moves from Pending to In Progress, Overdue, or Completed based on deadlines and phases. The audit score is the share of Pass results among Pass and Fail findings, color-coded green, amber, or red.
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Evidence Attached Where It Belongs
Attach supporting files and linked records to any finding or meeting through Related Items, including PDF, Office documents, and images.
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Connected to Corrective Action
Each corrective action on a finding links to a full CAPA event with its own investigation, status, and effectiveness check.
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Management and Quality Reviews
Track management reviews, quality reviews, and design reviews in the Meetings sub-module, and link a meeting to its related audit.
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Connect Other Systems
Read audits and findings, and create audits, from other systems through the eLeaP API with token-based access scoped to what each service needs.
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, link it directly to the training record in the training module. When a finding requires a document revision, Change Control is already connected. One audit. One traceable record. One system.
The Closed-Loop Difference
The eLeaP QMS and enterprise LMS are built together. When an audit finding generates a CAPA that identifies a training gap, the corrective action links to the training record, giving you documented evidence that the action included workforce competency.
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Every audit. One structured workflow.
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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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Training gaps linked directly to the LMS record.
Proven Benefits:
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Complete Traceability
Every finding links to a corrective action. Every corrective action links to its outcome. Every outcome links back to the finding that triggered it, 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 team assignment, finding, meeting, and corrective action is documented with 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
Scope fields, a risk rationale in the preparation phase, and linked risk items bring the ISO 19011:2018 risk-based approach into the audit record itself.
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Clear Ownership and Deadlines
Owners, response deadlines, and automatic status tracking make overdue audits and open findings visible without manual follow-up.
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Training Gap Closure
Because the QMS and LMS are built together, a corrective action that involves a training gap links straight to the training record in the LMS.
eLeaP Audit Management is trusted by organizations across the 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.
The Audit Management Module is part of the comprehensive eLeaP Quality Management System.
Audit Management FAQs
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Can I run supplier audits as well as internal audits?
Yes. Supplier audits can be added from the supplier record or generated by supplier policies, and the same audit module records findings, team, and meetings. See supplier management.
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How is the audit score calculated?
Pass findings divided by Pass plus Fail findings, as a percentage. N/A findings are excluded. A score of 80% or higher shows green, 60–79% amber, and below 60% red.
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How are corrective actions tracked?
Each finding can have one or more corrective actions, created in place or linked to an existing CAPA event. Actions move from Open to Verified, with actual completion dates and effectiveness notes.
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Does it support follow-up and surveillance audits?
Yes. Mark an audit as a follow-up and select its parent audit. A badge and a link back to the original audit keep the thread visible.
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Can we use our own audit checklists?
Yes. Audits are built from form templates you configure, with phases, sections, and mandatory fields. See events management.
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How can we try it?
Explore Related Capabilities
Audits work best connected to CAPA, suppliers, risk, and training in one system.
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Related Modules
CAPA management
Events management
Supplier management
Risk management
Training management -
Related Solutions
Medical device QMS
Pharmaceutical QMS
Aerospace QMS
Automotive QMS -
Next Step
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ISO 9001 eQMS readiness checklist