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CTMS Module 20 of 29

Inspection Readiness

Mock inspection tracking, document readiness, and regulatory authority preparation.

Module Overview

The Inspection Readiness module ensures continuous inspection readiness through mock inspection management, document readiness tracking, finding resolution, and regulatory authority preparation. It maintains a comprehensive inspection readiness scorecard across all study dimensions and provides audit trails for regulatory authorities.

Key Features

Mock inspection scheduling and finding tracking
Document readiness checklist with completeness scoring
Inspection finding management with response tracking
Regulatory authority preparation workflows
Inspection readiness scorecard across study dimensions
Audit trail and evidence package generation

Workflow & Interface

Explore the module's workflow through interactive interface mockups showing each step of the process.

1

Inspection Readiness Scorecard

Comprehensive readiness assessment across all study dimensions with scoring and gap identification.

medifirm-ctms — module view
87% — Ready
94% complete
78% complete
92% closed
96% complete
90% score
100% complete
Complete — 21 CFR Part 11
2

Mock Inspection Findings

Track findings from mock inspections with severity, response, and resolution status.

medifirm-ctms — module view

MI-001

Missing investigator CV at Site C

Minor — Resolved

MI-002

Consent form version mismatch

Major — Open

MI-003

Lab certification expired

Major — Resolved

MI-004

Source data gap for Visit 3

Minor — In Progress

MI-005

Training record incomplete

Minor — Resolved
3

Document Readiness Tracker

Track completeness of all inspection-critical documents with version and approval status.

medifirm-ctms — module view

Documents Ready

847/912

93% complete

Pending Approvals

23

Action needed

Mock Findings Open

4

2 major

Days to Inspection

45

On schedule

Module Connections

How Inspection Readiness integrates with other CTMS modules in the platform.

Receives fromQMS & CAPA

CAPA records available for inspection

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Receives fromDocument Approvals

Approved documents tracked for readiness

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BidirectionalRegulatory Vault

Inspection-ready documents in vault

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BidirectionalStudy Management

Study-level readiness assessed

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Receives fromTraining Compliance

Training records verified for inspection

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