Data Integrity:
Ensure the reliability and compliance of your data
Why Is Data Integrity crucial in regulated industries?
In the pharmaceutical, biotech, and healthcare sectors, data integrity is a fundamental pillar for ensuring traceability, safety, and regulatory compliance. Adhering to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) is essential to guarantee reliable information in environments regulated by 21 CFR Part 11 and EU GMP Annex 11.
Benefits of our Data Integrity solution
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Guaranteed regulatory compliance
We align your processes with FDA, EMA, and GMP regulations to eliminate non-compliance risks.
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Enhanced security and traceability
We implement controls to ensure the authenticity, reliability, and availability of data.
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Reduced operational risk
Minimizes errors and protects data integrity throughout the value chain.
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Digital process optimization
Ensures that electronic records are accurate and audit-ready.
Implement an effective Data Integrity strategy with our DIRA methodology. Comply with 21 CFR Part 11, EU GMP Annex 11 and ensure full data traceability.
Our DIRA methodology to ensure Data Integrity
We apply a structured approach based on DIRA (Data Integrity Risk Assessment), allowing companies to assess, control, and optimize the management of critical data. Our service includes:
- Policy and procedure development
Defining strategies to uphold data integrity across the organization. - Identification of relevant records
Detailed analysis of critical records within computerized systems. - Identification of data and metadata
Detecting and classifying key data to ensure full traceability. - Definition of data flows
Mapping data structure from generation to storage and retrieval.
