Data Integrity Trainingon
Importance of Data Integrity in Pharmaceuticals
Ensures patient safety and product quality. Supports regulatory compliance (FDA, EMA, WHO). Protects company reputation and mitigates risks. Enables accurate decision-making and traceability.
Data Integrity Lifecycle
Data Collection: Ensure accurate and reliable data entry.
Data Processing: Protect data from unauthorized modifications.
Data Review: Verify and validate data accuracy.
Data Storage: Secure data against loss or tampering.
Data Archiving: Maintain records for regulatory compliance.
Regulatory Guidelines and Compliance
FDA 21 CFR Part 11 – Electronic records and signatures
EMA Annex 11 – Computerized systems
WHO TRS 996 Annex 5 – Good data management practices
MHRA Data Integrity Guidance – Data integrity expectations
Best Practices for Data Integrity
Implement robust data management systems. Provide regular training on data integrity principles. Establish clear SOPs for data handling and review. Perform periodic data integrity audits. Implement data access controls and audit trails.
