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 ...

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 ...

Dublin, Sept. 18, 2024 (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 ...