Purpose-built electronic quality management systems are a better fit for CGT production than traditional technologies.

This article explores the US and EU compliance requirements to ensure patient safety for GMP ancillary materials in cell and ...

Looking at where the problems come from, Donzé suggests that many of the core data issues faced by businesses today stem from ...

Discover how to build a customized Microsoft document management system for your business with the workflows, security and ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...

Downeast Cider, with the help of the Revolution Group system integrator, changed its mode of operation from 50 spreadsheets to run its business to Plex MES, which provided a single source of data ...

Firms that perform audits, reviews, or compilations have a little more than four months to implement the new risk-based quality management (QM) standards. The task may feel daunting, but Joe Lynch, ...

Federal officials are scrambling to assess the damage and address flaws in a sprawling, heavily used computer system long known to have vulnerabilities. By Adam Goldman Glenn Thrush and Mattathias ...

The U.S. Federal Judiciary confirms that it suffered a cyberattack on its electronic case management systems hosting confidential court documents and is strengthening cybersecurity measures. The ...

In 2022, the Auditing Standards Board (ASB) issued new standards dealing with quality management (QM) that will become effective December 15, 2025. The ASB sets standards to be generally consistent ...

Office of Occupational Safety and Health, Office of the Chief Scientist, Office of the Commissioner, United States Food and Drug Administration, Silver Spring, MD, United States A laboratory quality ...