Seven-Gate QC
Amavita's six-step quality workflow for regulatory translations.
What it means
Seven-Gate QC is Amavita's quality workflow for regulatory and clinical translations. It runs structural inventory, numeric integrity, unit consistency, negation preservation, entity mapping, adversarial back-translation, and Document Currency — the 2026 addition that verifies every foreign-issued document sits within its jurisdictional validity window at the moment of filing. Each gate is documented and produces an audit trail that can be included in the submission package.
Why it matters for LATAM submissions
A documented multi-step QC workflow reduces the risk of translation-related rejection and gives sponsors a defensible record for audits and regulatory inspections.
Relevant regulators
Related terms
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