MockInspectionAudit

Mock-Inspection Audits – Be Inspection-Ready with Qualifyo

Identify compliance gaps before regulators do. Trust the global leaders in regulatory preparedness.

Introduction

In the highly regulated pharmaceutical industry, staying prepared for regulatory inspections is crucial to maintaining compliance, avoiding penalties, and safeguarding your reputation.

Mock-Inspection Audits act as a safety net, helping organizations identify gaps before actual inspections by authorities such as WHO, USFDA, or EU GMP. At Qualifyo, we bring decades of global expertise to simulate real-time inspection scenarios, ensuring your readiness and peace of mind.

Structured Approach to Mock-Inspections

How We Deliver

At Qualifyo, we adopt a structured, end-to-end approach for facility design and setup:

01

Pre-Audit Planning

Comprehensive understanding of your compliance history, processes, and existing quality systems.

02

Detailed Execution

Simulated regulatory inspections with a focus on key areas like documentation, process validation, and data integrity.

03

Gap Analysis

Identifying deviations, deficiencies, and risks compared to regulatory standards.

04

Actionable Insights

Providing detailed reports, risk categorization, and prioritized recommendations for corrective and preventive actions (CAPA).

04

Post-Audit Support

Assistance with CAPA implementation, training, and follow-up audits to track progress.

Actionable Results to Ensure Compliance

What We Deliver

Comprehensive Audit Report

A comprehensive audit report detailing observations, deviations, and compliance gaps.

Prioritized Action Plan

A prioritized action plan tailored to bridge gaps and align with global regulatory requirements.

Audit Prep Simulation

Simulated real-world inspection scenarios to prepare your team for actual audits.

Audit Response Training

Training sessions for your staff on addressing potential audit observations confidently.

Why Choose Qualifyo?

Global Expertise

We’ve collaborated with leading regulatory experts worldwide and possess deep knowledge of WHO, PIC/s, EU GMP, and USFDA standards
Customized Approach

Every mock inspection is tailored to your facility's unique processes and operational needs.
Proven Track Record

Trusted by top pharmaceutical organizations globally for robust, actionable results.
Holistic Support

Beyond audits, we offer end-to-end assistance, including corrective measures, training, and follow-up evaluations.
Proactive Compliance

Helping you prevent costly penalties, reduce operational risks, and safeguard your reputation.

ROI/Benefits for You

Unlock Tangible Value with Qualifyo’s Mock-Inspection Audits

Regulatory Readiness

Be 100% prepared for inspections with zero surprises.
Operational Excellence

Reduce the likelihood of non-compliance and unplanned production downtimes.
Team Preparedness

Equip your team to confidently face audits with hands-on training and clear guidance.
Cost Savings

Reduce the likelihood of non-compliance and unplanned production downtimes.
Improved Confidence

Build trust with stakeholders by demonstrating a robust compliance culture.

Take the Next Step Toward Inspection Readiness

Don’t wait for regulators to uncover gaps – act now to ensure your facility is always audit-ready.

Schedule Your Free Consultation

Speak with our compliance experts to evaluate your readiness today.

Book a Mock-Inspection Audit

Proactively identify gaps with our tailored audit services.