Anyone else losing their sanity during the 11th-hour eCTD manual QC loop?
Hey everyone,
I’m working on a lightweight tool to automate the worst parts of the midnight eCTD submission crunch, and I need your brutally honest feedback.
With agency automation getting tighter, spending hours manually hunting down formatting typos right before a deadline feels insane. I'm building a secure, private "Pre-Flight Compliance Guard" that lets you drag-and-drop your draft to auto-check three specific bottlenecks in 60 seconds:
- Text vs. Table Typos: Automatically flags metric/unit mismatches (e.g., text says 10 mg/mL but the table says 100 mg/mL).
- eCTD Path Sanitizer: Catches and renames paths that break the 200-character limit or contain illegal gateway characters.
- Hyperlink Validator: Crawls the compiled PDF to find broken internal links, cross-references, or missing leaf nodes.
Note: It runs on a zero-data-retention structure to protect proprietary IP.
If you work in RA or RegOps, would a micro-tool like this actually save your sanity during a crunch week, or am I totally missing the mark? What's your biggest manual headache?
u/TemporaryBeing4551 — 8 days ago