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Core Platform Module

Audit Management & Unified Assignment Framework

End-to-End Audit Planning, Field Execution, and Severity-Tiered Finding Closures

Plan and execute internal, supplier, and regulatory audits with digital checklists and direct evidence attachment. Findings flow seamlessly into corrective action workflows with mandatory auditee responses.

ISO 19011:2018FDA QMSR (21 CFR 820)ISO 13485:2016 §8.2.4EU GMP Chapter 9

Key Capabilities & Functional Architecture

01

Unified Assignment Framework

Cryptographically logs every change to an auditor or task owner for complete assignment accountability.

02

Severity-Tiered Finding Classification

Categorizes findings (Observation, Minor, Major, Critical) with automated CAPA linkage for critical issues.

03

Mandatory Auditee Response Phase

Auditees formally submit root cause investigations and remediation timelines before an audit can close.

04

Evidence Attachment Hub

Attach photos, interview notes, and document copies directly to individual checklist line items.

Built-In GxP Safeguards

Major/Critical finding closures require verified CAPA linkage.

Postponing an audit preserves the original planned date in the immutable audit trail.

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