Data Integrity

Module Lenght

From 1 to 2 days


Introduction on Data Integrity

  • Data Integrity definitions
  • Existing Regulatory overview
  • Data Life Cycle and Informatic Process
  • Data, metadata and true copy
  • Paper, ER-ES and hybrid systems

Criteria for Data Integrity

  • Principles of ALCOA+
  • Definition and analysis
  • Accurate data and audit-trail review introduction
  • Audit trail requirements
  • Audit trail review: Systems vs Process
  • Duties segregation and system quality
  • Data backup management

Complete data and Raw data (EU GMP and FDA perspectives)

Establishing Data Criticality & Inherent Integrity Risk for paper, ER-ES and Hybrid systems

Data governance description and key points

  • Data Integrity Policy
  • Data Ownership
  • Open Culture
  • Good Record Keeping Practises
  • Data Audits & Investigations

Paper vs ER-ES vs Hybrid systems

  • Electronic data system: advantages and criticalities

Comparison between GMP area and GLP area (critical issues)

GMP ER-ES Systems – Advantages and criticalities of the following ER-ES system architectures:

  • DCS
  • MES
  • Network and Interfaces

GLP ER-ES System – Advantages and criticalities of the following ER-ES system architectures:

  • Stand Alone
  • LIMS
  • CDS (Chromatography Data System)

Data Integrity Assessment

  • System Inventory
  • Evaluation check list
  • Quality Manual Analysis
  • Data Governance evaluation
  • Computerized Systems status evaluation
  • Analysis of Data Integrity Assessment (Analytical data)

Remediation Plan

  • Documentation management
  • Computerized System Validation Evaluation
  • System Safety Access
  • Deviation and CAPA management
  • Change control management
  • Back up and restore
  • Data storage
  • Disaster recovery and business continuity

Informatics process and PQ of the ER-ES systems

Informatics Process Validation

  • Computerized System Validation approach
  • Computerized System Interface validation approach
  • Analytical Instrument Validation approach
  • Hybrid system validation approach

Quality Assurance Role

  • Critical data definition
  • Identification of the Computerized System and their validation
  • Monitoring

Spreadsheet management and validation

Paper System: blank form management

Target audience

Information Technology

Quality Assurance

Quality Control



Supply Chain


Learning tools

  • Presentations
  • Lectures
  • Discussion
  • Question & Answers session
  • Final Evaluation Test

Regulatory & technical references


  • EU GMP Annex 11  – Computerized System
  • EU GMP Annex 15  – Qualification and Validation
  • EMA Q&A on website  – Note for Guidance on GMP for Data Integrity
  • FDA Guidance for Industry – Part 11 Electronic Records: Electronic Signatures: scope and applications
  • FDA Guidance for Industry – Process Validation: general principles and practises
  • FDA CFR 21 part 210-211-212 – Guidance for Industry – Data Integrity and compliance with GMP
  • 21 CFR part 11 – Electronic Records: electronic signatures: scope and applications
  • MHRA – MHRA GMP Data Integrity Definitions and Guidance for Industry
  • PIC/S – Good Practices for Computerized Systems in regulated “GXP” Environments
  • PIC/S – Good practices for data management and Integrity in regulated GMP/GDP Environments
  • ISPE GAMP 5 – The good automated manufacturing practices – a risk based approach to Compliant GxP Computerized Systems
  • ISPE GAMP – A risk based approach to GXP Process Control System
  • WHO – Guidance on good data and record management practises


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