Data Integrity
Module Lenght
From 1 to 2 days
Agenda
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:
- PLC & SCADA
- 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
Validation
Manufacturing
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