Radiopharmaceutical manufacturing software that understands half-life — not a repurposed small-molecule MES.
Half-life-decay-aware batch record, dose-calibrator readings bound to the record, USP 823 PET workflow, EU GMP Annex 3 alignment, hot-cell environmental stream, and Part 11 e-signature. The nuclear-medicine platform designed for a product that decays while you're still releasing it.
You're shopping for radiopharmaceutical manufacturing software because a small-molecule MES doesn't know what a half-life is.
Batch record does arithmetic on paper because MES ignores decay
Dose-calibrator readings are handwritten and later re-entered
USP 823 conditional release evidence is stitched together at inspection
Sterility, endotoxin and radiochemical purity results race the half-life
Hot-cell environmental data lives in a separate SCADA archive
Multi-dose distribution and site-specific labelling is a spreadsheet
The radiopharmaceutical workflow, modeled and enforced.
Half-life-aware batch record
Every activity capture is timestamped to the second and decay-corrected to reference time. The record does the math; the operator confirms it.
Dose calibrator bound to record
Calibrated activity readings pushed directly from the dose calibrator into the batch step. Out-of-cal instrument = locked step, not a deviation caught later.
USP 823 conditional release
Structured workflow for PET conditional release pending sterility — with the sterility result closing the loop automatically, not being reconciled by hand.
Hot-cell environmental stream
Pressure differential, temperature and radiation monitor readings bound to the batch record continuously. Excursions open a deviation with context.
Multi-dose site labelling
Per-dose activity, calibration time, expiry time and destination site rendered in-record and printed at the workstation. No retype.
Part 11 e-signature under time pressure
Bound e-signature designed for a workflow where the product is decaying — no 5-second UI stalls that eat your dose window.
What changes when a nuclear-medicine site has a real system.
- Batch-record arithmetic stops being a source of errors
- USP 823 conditional release closes automatically when sterility posts
- Dose-calibrator readings are captured live, not transcribed later
- Hot-cell excursions are contextualised in seconds, not archives-diving later
- Multi-dose distribution labelling stops being a spreadsheet
- Annex 3 inspector reads the whole batch end-to-end in the platform
Designed against the nuclear-medicine inspector's checklist.
USP <823> Positron Emission Tomography Drugs
PET production, quality control and conditional release workflow modeled natively — including sterility-pending release with automatic closure.
EU GMP Annex 3 (Manufacture of Radiopharmaceuticals)
Aseptic production of short-lived radiopharmaceuticals, hot-cell controls, radioprotection and QC-under-half-life expectations aligned end to end.
21 CFR 212 (PET Drugs)
cGMP for PET drugs — production, QC, personnel, facilities, equipment and records — modeled as first-class objects.
21 CFR Part 11
Bound e-signatures, hash-chained audit trail, RBAC. Reviewable, attributable, contemporaneous records per ALCOA+.
Radiopharmaceutical manufacturing software, answered.
What is radiopharmaceutical manufacturing software?
The system of record for a PET, SPECT or therapeutic radiopharmaceutical manufacturer — a half-life-aware batch record, calibrated activity capture from dose calibrators, hot-cell environmental data, QC integration (radiochemical purity, sterility, endotoxin), USP 823 conditional-release workflow and Part 11 audit trail. It replaces spreadsheets and small-molecule MES that don't know what decay correction is.
Does V5 handle USP 823 conditional release?
Yes. The batch is released conditionally when the physicochemical panel is complete, dispatched to the imaging site, and the release is auto-confirmed when the sterility result posts. If sterility fails, the recall workflow triggers automatically with the list of doses that shipped.
Does V5 integrate with dose calibrators?
Yes — calibrated activity readings are pushed directly from the dose calibrator into the batch step. If the calibrator is out of calibration, the step is locked and cannot be signed. No paper transcription.
Does V5 support EU GMP Annex 3?
Yes. Aseptic production of short-lived radiopharmaceuticals, hot-cell controls, radioprotection, environmental monitoring and QC-under-half-life expectations are all modeled and evidenced in-platform.
How long does implementation take?
Most PET production sites run their first signed batch within 30–45 days. Multi-cyclotron / multi-site rollouts typically take 3–5 months depending on dose-calibrator, HPLC and SCADA integration count.
Run radiopharmaceutical manufacturing on a system that knows the clock is ticking.
Free trial. Real half-life-aware workflow. No sales gate.