The National E-Health Transition Authority (NEHTA) is testing specifications and has almost recovered from its stumble that lead to it stopping e-health record trials, said NEHTA CEO Peter Fleming. In ...

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

Dublin, June 19, 2025 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" webinar has been added to ...

A risk-based guard band surrounds a specification limit and is derived from the uncertainty of the reportable value of the analytical procedure, which includes the uncertainty in the reference ...

If you would like to learn more about the IAEA’s work, sign up for our weekly updates containing our most important news, multimedia and more.