The Dot Compliance Blog
Your source for AI, quality, and compliance updates, insights and best practices across the life sciences industry.
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21 CFR Part 11AnnouncementArtificial IntelligenceAudit ManagementBest PracticesBiotechnologyCAPAChange ManagementClinicalComplaint ManagementCosmeticsData and AnalyticsDocument ManagementeQMSISO 13485Life SciencesManufacturingMedical DevicePharmaceuticalQuality 4.0Regulatory ComplianceRisk ManagementSaaSTraining Management

CAPA Management System: Requirements, Best Practices & Software
February 2026

How to Choose the Right QMS Software for Life Sciences
February 2026

What Does FDA-Compliant QMS Really Mean? (21 CFR Part 11 & 820 Explained)
February 2026

What Does ISO 13485 Require from a Digital QMS?
January 2026

What’s the Best Way to Align QMS with ISO 13485 and EU MDR?
January 2026

QMS vs eQMS: What’s the Difference and Why It Matters
January 2026

ISO 13485 Audit Checklist: What to Review Before Your Next Internal or External Audit
January 2026

Quality Management System (QMS) for Life Sciences: Pharma, Biotech & Medical Devices
January 2026

How Can a QMS Help Medical Device Companies Meet FDA 21 CFR 820 Requirements
December 2025

How Do Biotech Startups Use a QMS to Support Clinical Trial Readiness?
December 2025

How Do I Migrate from a Legacy QMS to a Modern Platform?
December 2025

Cosmetics QMS [Quality Management System]
December 2025