In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...

AICA currently supports auditing against 21 CFR Parts 11, 211, and 600, each mapped at the section and subsection levels.

Introduction to AuditsIn the fields of pharmaceuticals and medical devices where regulation is imposed, compliance with the quality standards set by the authorities is vital for the protection of the ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by ...

The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide ...

Hyderabad: Aurobindo Pharma Limited on February 27, 2026 announced the completion of a US FDA inspection at Unit I of its ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. The U.S. Food and Drug Administration took ...