This past August, FDA issued a warning letter to Soleetech Corp., a Taipei, Taiwan-based manufacturer of airway connectors. The agency was not impressed with this organization’s level of compliance.

DUBLIN--(BUSINESS WIRE)--The "3-Hour Virtual Seminar on Root Cause Analysis, CAPA and Effectiveness Checks" webinar has been added to ResearchAndMarkets.com's offering. This comprehensive course ...

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you ...

A new PCAOB spotlight report provides staff observations regarding the potential positive impact of performing a root cause analysis on the quality of audits performed by PCAOB-registered public ...

This all-in-one root cause analysis tool provides data scientists, ML engineers and analysts with a seamless and easy to navigate digital environment for real-time data analysis, root cause ...

One of the biggest changes in the 2020 FCPA Resource Guide, 2nd edition, is the addition of a new Hallmark, entitled, Investigation, Analysis, and Remediation of Misconduct, which reads in full: The ...

A few decades ago, simply knowing how your business was performing was a competitive advantage. Before computers, tracking and analyzing, even a handful of business metrics required dozens of people.

An accident must occur before root cause analysis can be performed, making it a reactive versus a proactive tool when it comes to improving safety. When accidents happen, organizations analyze them to ...

When there’s a major systems outage or performance issue, IT teams come to the rescue to restore services as quickly as possible. Some IT organizations follow IT service management (ITSM) incident ...

Aporia, a machine learning (ML) observability platform, today announced the launch of a tool that aims to ease investigation of production data. The company asserts that its Production Investigation ...