QMS for Biotech Startups: A Build vs. Buy Analysis
An in-depth analysis of the build vs. buy decision for a quality management system (QMS) in biotech startups. Explore costs, timelines, and compliance factors.
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Articles tagged with “fda-compliance”
21 CFR Part 11 for AI Systems: An FDA Compliance Guide
Navigate FDA 21 CFR Part 11 for AI systems. This article details compliance strategies for validation, audit trails, and data integrity in regulated GxP setting
FDA Compliance Monitoring: A Guide to Top Software & Services
An educational review of top FDA compliance monitoring companies. Compare leading QMS software platforms and expert regulatory consulting firms for pharma & med
Validating Generative AI in GxP: A 21 CFR Part 11 Framework
Explore a risk-based framework for validating generative AI in GxP systems. Learn how to meet 21 CFR Part 11 rules, ensure data integrity, and apply CSA princip
Git Version Control for FDA and IEC 62304 Compliance
Examines how to apply Git version control workflows to satisfy FDA compliance, covering traceability, audit trails, and standards like 21 CFR Part 11 & IEC 62304.
21 CFR Part 11: Electronic Records, Signatures, AI, GxP Compliance
Explore 21 CFR Part 11 compliance for electronic records, signatures, and AI in GxP. Covers key elements, FDA guidance, and controls for data integrity and audit-ready systems.