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GMP Facility Assessment & Regulatory Gap Analysis

GMP Facility Assessment & Regulatory Gap Analysis

Service Overview

Process industry facility projects whether new cleanroom construction, existing facility upgrades for new product lines, or regulatory remediation programs begin with a thorough understanding of existing conditions and regulatory gaps. Desapex’s digital assessment creates a verified 3D baseline that maps facility conditions against strict regulatory requirements.

Our Digital-First Approach

Deploy Reality Capture

Deploy laser scanning to capture existing facility conditions, including room geometries, HVAC ductwork, process piping, and material flow paths.

Overlay Classifications

Overlay regulatory zone classifications (ISO clean room grades, ATEX zones, containment categories) on the 3D model.

Overlay Classifications

Overlay regulatory zone classifications (ISO clean room grades, ATEX zones, containment categories) on the 3D model.

Analyze Gaps

Create a visual regulatory gap analysis showing exactly where the facility meets, and where it fails, the applicable standards.

Analyze Gaps

Create a visual regulatory gap analysis showing exactly where the facility meets, and where it fails, the applicable standards.

Core Deliverables

  • Existing facility scan-to-BIM capturing room layouts, HVAC systems, process piping, and flow paths.

  • Clean room classification mapping with ISO 14644 zone visualization overlaid on the 3D model.

  • HVAC system and utility capacity assessment.

  • Personnel and material flow analysis to identify potential cross-contamination risks.

  • Regulatory gap identification report mapping conditions against cGMP, FDA, EU GMP, FSSAI, or WHO standards.

Why Choose Desapex

3D-visualized regulatory analysis enables facility teams to understand compliance gaps spatially seeing exactly where air pressure cascades fail or where clean utility routing conflicts with non-GMP areas. This spatial understanding leads to more targeted, cost-effective remediation than traditional 2D-based assessments.

Unique Selling Proposition

Our USP is that Desapex’s regulatory gap analysis is embedded in the 3D model, not presented as a separate text report. Every non-compliance finding is linked to a specific location in the model, making the remediation scope unambiguous and enabling accurate cost estimation.

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Let’s make your next project on time and within budget.

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Let’s make your next project on time and within budget.

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Let’s make your next project on time and within budget.