BLOG
Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Using Your QMS to Support cGMP Compliance
In FY 2023, the majority of warning letters issued to pharmaceutical manufacturers by the U.S. Food and Drug Administra [...]
AI in Medical Device Manufacturing: How It’s Transforming an Industry
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first AI-powered diagnostic system, a software [...]
FDA Inspection Expectations in 2025
The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspections of regulated manufacturers’ facilit [...]
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operat [...]
How Compliance Software Can Help Manage CIP-007: Strengthening Critical Infrastructure Security
In today’s interconnected digital landscape, ensuring the security and integrity of critical infrastructure systems is [...]
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rule harmonizing its Quality System Regulat [...]
