OPDP publishes the errors it sees most often in promotional eCTD submissions. Most are structural, most are silent, and several fail in ways that are not obvious from the rejection notice.
Where each piece of a Form FDA 2253 submission belongs in the eCTD — the form, the current labeling, and the promotional material itself — and why the placement is not obvious from the guidance alone.
One design rule makes AI defensible in regulated environments: AI output is always a draft until a human approves it into the record. Here is how that boundary works in practice.
A submissions grid that took 12 seconds to load was issuing one database query per row. The fix took the page to 0.7 seconds — and taught us why performance is an adoption and compliance issue.
Can regulated software fix itself? Yes — within a strict boundary. The rule we use to decide what heals automatically, what escalates to humans, and why every heal writes an audit record.
We automated 50+ operational qualification scripts and learned that the hard part isn’t automation — it’s honesty. How to build OQ evidence a QA auditor can actually trust.
In regulated software, a false success is worse than a crash. Three real silent-failure stories from our own platform, the engineering discipline that eliminates them, and what buyers should ask vendors.
Audit preparation should not be a three-week fire drill. How continuous readiness scoring, one-click audit packs, and mock inspection mode turn inspection prep into a standing capability.
Most ‘AI search’ in regulatory software is keyword matching with a chat interface. Here is what true vector retrieval looks like, why citations are non-negotiable in GxP, and how we proved ours works.
DnXT’s auto-assign engine places documents into eCTD sections using patterns mined from 3,081 real sequences — deterministic first, AI last, and every placement explainable.
