Stay informed with the latest regulatory updates, best practices, and compliance guidance
Overview of FDA's latest guidance on artificial intelligence and machine learning validation requirements for medical device software.
Practical strategies for maintaining ALCOA+ principles when migrating GxP data to cloud platforms.
How a mid-size pharma company achieved compliant SAP validation in 6 months using risk-based GAMP 5 approach.
Analysis of the finalized EU GMP Annex 1 on sterile manufacturing and its impact on computerized systems.
Balancing regulatory requirements with modern DevOps practices for continuous compliance.
New WHO expectations for data integrity controls in pharmaceutical quality systems.
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40-page comprehensive guide covering GAMP 5, risk-based validation, and lifecycle management
Practical checklist for assessing ALCOA+ compliance across your GxP systems
Step-by-step framework for achieving and maintaining Part 11 compliance
Risk-based approach to moving validated systems to cloud infrastructure
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