blog | 21 CFR Part 11

Top 10 Data Integrity Requests During a Life Sciences Audit

14 Nov 2024

Dr Eva Kelly

In today’s life sciences industry, ensuring data integrity is crucial to maintaining regulatory...

High reliability, Data Integrity, 21 CFR Part 11, Annex 11, GAMP5, ALCOA Plus, Computerized Systems Inventory List, Data Integrity Audits

The Importance of a GxP Computerized Systems Inventory in Life Sciences

1 Nov 2024

Ben O'Brien

In life sciences, compliance isn’t just about following rules—it’s about safeguarding patient...

High reliability, Risk, Risk assessment, Resilience, Data Integrity, Data integrity culture, Data flow maps, Data backup and restore, 21 CFR Part 11, Digital transformation, Annex 11, GAMP5, ALCOA Plus, Data Migration, Computerized Systems Inventory List, Phanero

People in a futuristic office representing digital transformation

Navigating Digital Transformation, while assuring GxP Compliance

9 Oct 2024

Andy O'Connor

For clinical-stage life sciences companies, the transition to digital systems is critical for...

Data Integrity, 21 CFR Part 11, Digital transformation, Clinical, Annex 11, GAMP5, ALCOA Plus

21 CFR Part 11

Top 10 Data Integrity Requests During a Life Sciences Audit

The Importance of a GxP Computerized Systems Inventory in Life Sciences

Navigating Digital Transformation, while assuring GxP Compliance

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