Following the launch of its initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," FDA has been looking to process analytical technology (PAT) for improvements in process ...

Editor’s note: This article is the first in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. In June 2022, the AICPA’s Auditing ...

After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their ...

Firms that implemented a new quality management (QM) system early have had time to test the new approach, detect gaps, and improve what’s not working as well as they expected. Anders started to design ...

The implementation of a process based management system is challenging for many organizations accustomed to traditional, non-integrated, non-process based approaches to management systems. This ...

The adoption of a quality management system (QMS) should be a strategic decision of a Nuclear Medicine service. Its design and implementation will be influenced by various factors, for example the ...

This study examines staff perceptions of patient care quality and the processes before and after implementation of a comprehensive clinical information system in 7 critical access hospitals.

Quality management systems are really just about one thing: quality. But assuring quality in your products and services has a nice ripple effect of increasing customer satisfaction and keeping them ...