Half of all FDA investigator site inspections find GCP non-compliance. Informed consent is consistently among the highest-frequency findings across FDA and EMA inspections.
The sites that failed had complete training records. The problem was never knowledge. It was judgement. DOKIMA trains the judgement that prevents the finding.
DOKIMA does not replace baseline GCP training. It closes the judgement gap that remains after baseline GCP training is complete.
DOKIMA is built by a Quality Assurance professional with twenty-five years across the GxP lifecycle in pharmaceuticals and biotechnology, with engagement experience spanning twelve health authorities including the FDA, EMA, PMDA, MHRA, TGA, Health Canada, Anvisa, NMPA, MFDS, Taiwan FDA, DCGI and HSA.
The judgement DOKIMA trains is not theoretical. It is drawn from a career spent holding the line between commercial urgency and patient safety, and from asking the questions that matter before the inspector does.
Every module moves from a real inspection finding, through branching judgement, to a defensible examination. Here is what a learner sees.
DOKIMA is released module by module, highest-risk principles first. Design-partner and early-access licensees shape the sequence.
Whether you are exploring a pilot, asking about licensing, or want to understand how DOKIMA fits your inspection readiness programme — we respond within 24 hours.
Sachin Pasumamula is the Founder and CEO of Sparsh Strategic Consulting Pte. Ltd. with 25+ years of GxP quality assurance expertise across Asia Pacific. He is also the author of Quiet Watchdogs: The Unsung Heroes of GxP and the inventor of SQIP — the world's first Causal Quality Intelligence Platform (patent filed, Singapore, April 2026).