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Audit Preparation: A Comprehensive Guide

Regulatory audits don’t have to be stressful. With proper preparation and a systematic approach, you can demonstrate compliance and turn audits into opportunities for improvement.

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Types of Audits

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Internal Audits

Self-assessments to identify gaps before external reviews

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Supplier Audits

Verification of vendor compliance and quality systems

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Regulatory Audits

FDA, Notified Body, or other authority inspections

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Customer Audits

Due diligence by current or prospective customers
This guide focuses primarily on regulatory audits, but many principles apply to all audit types.

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The 90-Day Audit Preparation Plan

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Days 90-60: Foundation Phase

1

Assemble Audit Team

  • Designate audit coordinator
  • Identify subject matter experts
  • Assign backup personnel
2

Documentation Review

  • Verify all SOPs are current
  • Check document control records
  • Review training records
3

Facility Preparation

  • Schedule deep cleaning
  • Organize storage areas
  • Update facility diagrams

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Days 60-30: Intensive Preparation

Conduct comprehensive mock audits:
  • Use recent regulatory trends as guide
  • Involve cross-functional teams
  • Document findings and create CAPA
  • Practice opening and closing meetings
Focus on high-risk areas:
  • Audit trail completeness
  • Data backup and archiving
  • Electronic signature compliance
  • Metadata integrity
Address findings from mock audits:
  • Prioritize by risk level
  • Document corrective actions
  • Update procedures as needed
  • Retrain personnel

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Days 30-0: Final Preparations

Team Training

  • Conduct audit response training
  • Review question handling techniques
  • Practice document retrieval

Logistics

  • Confirm audit schedule
  • Prepare conference rooms
  • Set up document staging area

Response Protocols

  • Establish communication plan
  • Define escalation procedures
  • Prepare emergency contacts

Final Walkthrough

  • Tour facility as auditor would
  • Verify cleanliness and organization
  • Check equipment calibration status

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Critical Documents to Have Ready

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Quality System Documentation

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Product-Specific Documentation

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CAPA and Complaints

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During the Audit: Best Practices

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Day 1: Opening Meeting

First Impressions Matter: Be professional, organized, and welcoming. Provide clear facility overview and safety briefing.
Key points for opening meeting:
  • Company overview and products
  • Quality management system summary
  • Organizational structure
  • Manufacturing processes
  • Recent significant changes

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Document Requests

When auditors request documents: 
DO:
✅ Listen carefully to the request
✅ Repeat back to confirm understanding
✅ Provide exactly what was requested
✅ Note the request in your tracking log
✅ Provide documents in organized manner

DON'T:
❌ Volunteer additional information
❌ Provide outdated versions
❌ Make excuses for missing documents
❌ Provide uncontrolled copies
❌ Rush or appear flustered

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Answering Questions

  • Answer only what is asked
  • Be honest and direct
  • Say “I don’t know” if you don’t know
  • Offer to find the answer
  • Stay calm and professional
  • Contradicting other team members
  • Discussing non-documented practices
  • Making defensive statements
  • Promising things you can’t deliver
  • Speculating about future plans
  • Request clarification if needed
  • Take breaks when necessary
  • Escalate to management when appropriate
  • Document all discussions
  • Stay focused on facts

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Facility Tour

Prepare your team:
AreaFocus PointsCommon Issues
ManufacturingCleanliness, organization, adherence to proceduresUnlabeled materials, expired items
WarehouseTemperature monitoring, FIFO, segregationMixed lots, damaged packaging
QC LabEquipment calibration, raw data, test methodsIncomplete records, deviations
Document ControlVersion control, archive systemObsolete docs in use

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Closing Meeting

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What to Expect

Auditors will present:
  • Summary of inspection activities
  • Observations and findings
  • Classification of findings (if applicable)
  • Expected timeline for formal report
Critical: Take detailed notes during closing meeting. These notes will be essential for developing your response.

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Responding to Findings

1

Acknowledge

Accept findings without being defensive
2

Investigate

Conduct thorough root cause analysis
3

Correct

Fix immediate issues
4

Prevent

Implement systemic improvements
5

Document

Create comprehensive CAPA records
6

Verify

Confirm effectiveness of actions

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Post-Audit Activities

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Immediate (Days 1-7)

  • Debrief with audit team
  • Secure all audit-related documents
  • Begin root cause investigation
  • Draft preliminary response

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Short-term (Days 7-30)

  • Complete CAPA investigations
  • Implement corrective actions
  • Update relevant documentation
  • Conduct verification activities
  • Submit formal response to auditor

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Long-term (Months 1-6)

  • Monitor effectiveness of CAPAs
  • Conduct follow-up training
  • Update risk assessments
  • Schedule verification audits
  • Prepare for potential re-inspection

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Common Audit Findings

  • Inadequate audit trails
  • Unsigned or undated records
  • Retroactive data entry
  • Uncontrolled spreadsheets
  • Insufficient management review
  • Inadequate internal audits
  • Weak corrective action systems
  • Poor document control
  • Inadequate validation
  • Missing or incomplete batch records
  • Unqualified equipment
  • Insufficient process monitoring

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Comeply’s Audit Readiness Solution

Continuous Monitoring

Real-time compliance status dashboards

Mock Audit Tools

Automated internal audit scheduling and tracking

Document Readiness

Instant access to organized documentation

CAPA Management

Streamlined investigation and tracking

Be Audit-Ready Every Day

Discover how Comeply keeps you prepared for audits year-round.

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Audit Preparation Checklist

Download our comprehensive audit preparation checklist:

Complete Audit Prep Checklist

90+ items covering all aspects of audit preparation

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Key Takeaways

Remember: The goal is not to hide problems but to demonstrate:
  • You have robust systems in place
  • You know your processes
  • You identify and address issues proactively
  • You have a culture of continuous improvement