PET · SPECT · Therapeutic Radiopharmaceuticals · USP 823 · Annex 3
Radiopharmaceutical manufacturing software built around short production windows.
Time-stamped batch record for short production windows, QC results tracked as available or pending, human release review and Part 11 e-signature. The nuclear-medicine platform designed for a product that decays while you're still releasing it.
Time-Stamped Batch Record
Readings recorded at the step
QC Status and Release Review
Equipment and Calibration Readiness
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping for radiopharmaceutical manufacturing software because a small-molecule MES doesn't know what a half-life is.
Batch steps, QC status and release evidence sit in separate paper and spreadsheet records
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
Equipment, calibration and service readiness live in another log
Multi-dose distribution and site-specific labelling is a spreadsheet
The radiopharmaceutical workflow, modeled and enforced.
Time-Stamped Batch Record
Each step and entered reading is time-stamped and signed in the record.
Readings recorded at the step
Readings are entered against the batch step, time-stamped and attributed. Instrument connections, if any, are scoped per site; confirm them with the V5 team.
QC Status and Release Review
QC results are shown as available or pending beside the release review, so qualified people make and record the decision. V5 never releases a batch itself.
Equipment and Calibration Readiness
Hot-cell and synthesis equipment, calibration and service status sit in one maintained register, with deviations recorded and reviewed by your team.
Multi-Dose Site Labelling
Per-dose activity, calibration time, expiry time and destination site rendered in-record and printed at the workstation.
Part 11 e-Signature under Time Pressure
Bound e-signature designed for a workflow where the product is decaying — quick to complete when the production window is short.
What changes when a nuclear-medicine site has a real system.
- Recorded calculations and entries are easier to check at review
- QC status and release review sit together in one record
- Readings are entered at the step, time-stamped and attributed
- Deviations are recorded against the batch they affect
- Multi-dose distribution labelling stops being a spreadsheet
- Inspectors can see the available batch, QC, deviation and release-review records together
Designed against the nuclear-medicine inspector's checklist.
USP <823> Positron Emission Tomography Drugs
Records supporting PET production, QC and human release review. Whether a release pathway applies to your product is your regulatory decision.
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 time-stamped batch record, QC results tracked as available or pending (for example radiochemical purity, sterility, endotoxin), USP 823 conditional-release workflow and Part 11 audit trail. Activity, decay, dose and release decisions stay with qualified people.
Does V5 handle USP 823 conditional release?
V5 keeps QC results (available vs pending), the release review and linked dispatch records together so qualified people can make and record their decision; it never releases a batch itself. Whether a release pathway applies to your product is your regulatory decision. Confirm specific conditional-release steps with the V5 team.
Does V5 integrate with dose calibrators?
Readings can be entered against the batch step, time-stamped and attributed. Any direct instrument connection is scoped per site and should be confirmed with the V5 team before you rely on it.
Does V5 support EU GMP Annex 3?
V5 holds batch, QC, deviation, equipment and training records that can support an Annex 3 programme. Environmental-monitoring data handling should be confirmed with the V5 team; compliance remains your responsibility.
How long does implementation take?
Timing depends on your scope, records, any integrations and your validation approach. The V5 team will scope it with you.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Run radiopharmaceutical manufacturing on a system that knows the clock is ticking.
Free trial. Real half-life-aware workflow.