FilePreserveThe pain shows up mid-audit, not during evaluation.
No single screen shows the whole case
There's no standard CAPA object because the FDA's own process — intake, investigation, root cause, corrective action — doesn't map to one record type. Most orgs end up with three or four related objects (whether custom-built or from a QMS module like ComplianceQuest), each with its own attachments and its own tab.
Storage costs push toward archiving
Salesforce's own file storage is priced well above commodity cloud storage, and complaint/investigation attachments accumulate indefinitely without an active archiving discipline — but archiving with a separate vendor usually breaks retrieval exactly when you need it most.
A short window, real consequences
An FDA Form 483 or Warning Letter response is due within 15 business days — a fixed, fast deadline — and a late or incomplete response is itself something an investigator can cite. Assembling a complete packet by hand, under that deadline, is exactly when a manual or multi-tool process fails.
One packet, whether the files are live or already archived.
- Complaint intake, investigation notes, and CAPA docs assembled by hand
- Any file already archived by a separate vendor needs manual restore first
- A regulator's short-notice request means scrambling across several tools
- Pick whichever files you need across any related list
- Archived files are pulled back in automatically the moment they're selected
- One audit-ready PDF, on demand, whether files are live or archived
Point FilePreserve at your own CAPA object model.
Archive jobs are config-driven — pick the object, set your filter criteria, done. The setup guide walks through exactly how.