Validation notes
No Part 11 / audit / e-sign in codebase; controlled install, licenses, methods, exports.
Honest scope for QA / CSV / IT: what Quanto does not claim, and what labs can still control.
What was not found in the codebase
Quanto does not implement 21 CFR Part 11-style audit trail, electronic signature, or dedicated electronic-record controls as product features. Do not document or market the desktop app as Part 11 compliant on the basis of this release.
Instrument licensing (Licensing) and prerelease expiry are not substitutes for Part 11 controls.
What labs can still do
Practical controls that do not require inventing missing features:
| Control | How |
|---|---|
| Controlled install | Fixed path C:\Program Files\Quanto; silent deploy (Silent deploy); pinned build |
| License folder | Shared LicenseFolder / Public Documents license path; restricted write |
| Method packages | Versioned .qtm on a controlled share; Replace vs Append discipline |
| Batch packages | Study folder + QuantoResults\*.qtb next to raw data; backup policy |
| Export evidence | Excel / PDF report export with baked plots (Reports) |
| Permissions | NTFS on Program Files, license folder, study shares (Installation) |
| Reset / support | Shift+splash recycle; Recovery zips under Local AppData |
Prerelease expiry
Alpha / prerelease binaries expire 60 days after build (SplashIdentity.ExpirationDaysAfterBuild). That is separate from instrument serial licenses. Plan upgrades before expiry; do not treat expiry as a validation audit feature.