DIRA Data Integrity Risk Assessment: complete operational method

The DIRA – Data Integrity Risk Assessment is a fundamental operational tool for evaluating and mitigating risks to GxP data. Below is a practical, methodical guide based on the best practices described in the ALCOA+ & Data Governance manual.

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1. Define the scope

Specify what you are assessing:

• a system (e.g., LIMS, HPLC)
• a process (batch record review, weighing, deviation management)
• a department (QC, Manufacturing)

An effective DIRA requires a clearly defined scope.

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2. Build the team

Always include:

• QA (compliance oversight)
• IT/CSV (for computerized systems)
• process experts (analysts, operators)
• Data Owner
• department manager

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3. Map the data flow

This is one of the most critical phases.
Map all stages of the data lifecycle:
generation → recording → processing → review → archiving → retrieval → destruction

For each step, identify:

• people involved
• instruments and systems
• media (paper/electronic)
• potential risks

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4. Identify the risks

For each point, analyze the 9 ALCOA+ attributes:

• Attributable: shared accounts, missing signatures
• Legible: illegible forms, obsolete formats
• Contemporaneous: backdating, late entries
• Original: modifiable raw data, uncontrolled copies
• Accurate: calculation errors, untracked re-integrations
• Complete: missing data, partial saves
• Consistent: inconsistent timestamps
• Enduring: perishable or unstable media
• Available: unrecoverable data or untested backups

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5. Evaluate severity × probability × detectability

Use a qualitative scale (high/medium/low) or numerical scoring.
Identify which risks are unacceptable.

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6. Identify existing controls + gaps

Examples of controls:

• active audit trail
• double signature / four-eyes principle
• controlled forms
• automatic backups
• validated calculations
• individual user access

Identify what is missing or insufficient.

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7. Mitigation actions

Concrete examples from the guide:

• enable the audit trail and review it weekly
• introduce an SOP for manual chromatogram integration
• eliminate shared accounts
• implement centralized backups with restore testing
• require mandatory justification for HPLC reinjections

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⚠️ Watch out for…

• overly generic analyses (not accepted by inspectors)
• failure to document criteria and scoring
• relying only on organisational measures without technical controls
• classifying all risks as “medium/low” without justification

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🔧 How to handle a non-conformity

If the DIRA reveals severe risks (e.g., non-recoverable data, disabled audit trail):

• open a deviation
• perform a root cause analysis
• implement technical and organisational CAPAs
• update the DIRA after implementation

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🧰 GMP Best Practices

• Always document methods, assumptions and assessment criteria
• Involve end users who know the real process
• Link DIRA actions to the CAPA system
• Review the DIRA annually or after process changes

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Condensed operational checklist

• Scope defined
• Complete data flow mapping
• ALCOA+ analysis for each step
• Risk scoring with clear criteria
• Gaps identified
• Mitigation actions assigned to owners
• Actions integrated into CAPA
• Periodic review scheduled

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Realistic use case

QC HPLC system:

• Risk: manual reintegration without audit trail → high
• Action: enable audit trail + SOP for integration justification + QA spot-check review

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Conclusion

A well-executed DIRA reduces risks and deviations, strengthens data quality, and ensures audit readiness.
Explore the complete guide on GuideGxP.com