Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

Implementing the new standard on quality management (QM) by the Dec. 15, 2025, deadline may seem daunting, but the AICPA has developed resources and tools to get started, including a recently revised ...

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 ...

Research personnel must perform a process risk assessment for all processes that utilize hazardous materials. The assessment is utilized to determine the level of risk associated with a specific ...

In the first stage of the ISO 31000 risk management process, organizations should establish the context of the risk assessment as it relates to both internal and external factors. The most important ...

Governance, risk and compliance-related residual risks are risk factors left over after an organization applies security controls to ensure compliance with laws and regulations. It's important to ...

Chemical regulations exist to safeguard human and environmental health throughout a substance’s life cycle (sourcing, manufacture, intended use phase, and disposal). Regulatory decisions require ...

Safety risk assessments are becoming a preferred regulatory tool around the world. Online safety laws in Australia, Ireland, the United Kingdom, and the United States will require a range of providers ...