Blog
Field notes from the front lines of quality.
10 Oct 2026
Retraining Is Not a CAPA: Making Human-Error Investigations Count Under ICH E6(R3)
Open almost any deviation log at a site, CRO or sponsor, and you will find the same three lines repeated:
1 Oct 2026
Small and Emerging Biotech, Big Expectations: When Fractional Quality Makes Sense
A typical biotech startup today has twenty people, one lead asset and a long list of partners. A CDMO makes the drug. A CRO runs the trial. A central lab tests the samples. An EDC vendor holds the data, another vendor handles safety, and a