Digital quality
Stay audit-ready without burying a small team. Digital quality that growing manufacturers can live with — and an inspector can trust.
Records, training, and yield live apart. Inspection asks one story.
01
Events that never open a CAPA or retrain a role.
02
Protocols written once, then left behind.
03
Chat tools that invent citations. People still sign.
Start with the quality file. Add intelligence when you need it.
The operating system for quality.
Intelligence on the same quality file.
The same quality anatomy: documents, deviations, training, suppliers, evidence.
cGMP under 21 CFR 210/211, EU GMP, and ICH Q10.
Cell, gene, and vaccine programs with a clean validation story.
ISO 13485, FDA QMSR, and EU MDR — design to post-market.
Assay, instrument, and software-as-IVD quality in one system.
Multi-product sites, client quality agreements, batch control.
GCP document control and training sponsors can inspect.
Background photographs via Unsplash.
45 minutes
Forty-five minutes. Bring an SOP, a deviation, or a validation gap.
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