Decay-corrected batch records, conditional release, hot-cell ready.
Built for 21 CFR 212 (PET), 21 CFR 210/211, USP <823>, and NRC / state radioactive materials licensing.
← Different industryThe codes you're accountable to — at the data layer.
Five steps from receive to release — with the regulator on the hook at the end.
Tap to expand · download as PNG · paste into an audit prep deck.
From login to release — no end-of-shift paperwork.
- › isotope
- › A₀ (MBq)
- › calib time
- › manifest
- › A(t)=A₀·e⁻ᵏᵗ
- › λ / T½
- › target dose
- › calc by
- › hot-cell run
- › yield
- › QC sample
- › operator
- › dose (MBq)
- › calib at
- › patient ref
- › operator
- › radiochem purity
- › endotoxin
- › QP sig
- › conditional
- › A at calib
- › transport idx
- › carrier
- › ETA
- T-zero·step 01Calibrate to T0
Activity calibrated to the reference time — every later step decays from this anchor with A(t)=A0·e^(−λt).
- T+15·step 02Synthesis
Cyclotron / synthesiser captures yield + activity. Operator has decay-corrected display, never raw counts.
- T+45·step 03QC + sterility
Conditional release: shipment goes out before sterility result, then retroactive sign-off when sterility completes.
21 CFR 212.70(d) - T+60·step 04Unit-dose dispense
Each patient dose dispensed at calibration time. Activity at administration is the dispense activity decayed forward.
- T+24h·step 05Retroactive sterility sig
When the sterility test reads negative, the conditional release is finalised. Record locks. If positive → recall protocol fires.
The terms your auditor uses
- PET
- Positron Emission Tomography — imaging using positron-emitting radiopharmaceuticals (e.g. 18F-FDG).
- Half-life
- Time for activity to decay to 50%. Drives the entire production + dispense schedule.
- Conditional release
- Shipping the lot before sterility completes (212.70(d)) — sterility result attaches retroactively.
- T0 / calibration time
- Reference time the activity is reported at — every dose is decayed from this anchor.
- Becquerel / Curie
- Units of activity. 1 Ci = 3.7×10¹⁰ Bq.
- Hot cell
- Shielded enclosure where radiopharmaceutical compounding happens.
Sound familiar? We built this for you.
Decay correction lives in spreadsheets — every batch a manual re-calc, every transcription a deviation waiting to happen.
PET conditional release per 212.70(d) is paper-based; sterility close-out lags the dose by hours and never ties cleanly back to the batch.
Patient unit-dose dispense records (activity at injection time, syringe ID, calibration time) are reconstructed after the fact.
Survey, wipe-test, TLD, and decay-in-storage waste logs sit in three different binders and four different systems.
NRC / state license inspections turn into a week of re-assembly because no system carries the license number through to the records.
The workflows you'd expect to see on day one.
Not a generic feature list — these are the specific radiopharma workflows V5 ships configured for, ready to run on your batches.
Isotope intake & A₀ capture
Isotope, activity at calibration, half-life, and manifest data captured at receive.
Real-time decay correction
A(t) = A₀·e^(−λt) computed live for every dose — at dispense, ship, and patient calib time.
Unit-dose dispensing
Per-patient dose, calibration time, and operator e-sig — short half-life products handled by the system, not the spreadsheet.
Conditional QC release
Radiochemical purity, endotoxin, and sterility tracked with conditional release per 21 CFR 212 / Annex 3.
QP / RP release sign-off
Qualified Person / Responsible Pharmacist e-sig with full chain of custody.
Transport index + carrier handoff
TI, package label, and carrier manifest computed from current activity at ship time.
The record assembles itself as the work happens.
No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.
Built-in isotope master
Pb-212, Ac-225, Lu-177, F-18, Tc-99m, Ga-68, I-131 and more — half-lives, decay modes, default shelf-lives all wired in. Decay correction A(t)=A₀·e^(−λt) at every read, no spreadsheets.
Calibration-time batch record
Every work order carries a calibration datetime. The BMR records activity AT calibration; every later read auto-decays from there.
Conditional release with forced close-out
Per 212.70(d) — release the dose for patient use before sterility testing completes, with a system-enforced retroactive sterility sign-off that ties back to the original batch and operator.
Patient unit-dose dispense
One synthesis, many patient doses. Each dose has its own calibration time, syringe ID, and decay-corrected activity at injection — captured live, signed by the dispenser.
Two-signature batch release
Same 211.186 / 211.188 discipline as conventional pharma — preparer + independent reviewer e-sigs, immutable batch record, snapshot-from-MMR construction.
Plain-English playbooks for Radiopharma regulations.
Structure, recurring inspection findings, and a practical 60-day path — written for QA, regulatory and operations leads.
Plain-English guide to FDA 21 CFR Part 11 — electronic records, electronic signatures, audit trails, and a practical path to a Part 11-compliant eQMS without theatre.
Plain-English guide to the Drug Supply Chain Security Act (DSCSA) — serialization, aggregation, EPCIS exchange, verification, and the path through enhanced drug distribution security.
Plain-English guide to EU Good Distribution Practice (2013/C 343/01) — Responsible Person duties, temperature control, qualifications, falsified medicines, and inspection.
A practical, audit-ready walkthrough of EU GMP Annex 11 — what each clause means, what inspectors look for, and how to evidence compliance for any GxP system.
Plain-English guide to GAMP 5 second edition and FDA's Computer Software Assurance — software categories, risk-based testing, intended use, and a leaner validation pack.
Plain-English guide to the ISPE GAMP Records & Data Integrity (RDI) Good Practice Guide — ALCOA+, data lifecycle, hybrid records, audit trail review, and a defensible RDI programme aligned with MHRA, FDA, WHO and PIC/S expectations.
Plain-English guide to ICH Q10 — the global Pharmaceutical Quality System. Management responsibilities, lifecycle stages, enablers, and a practical implementation path.
Plain-English guide to ICH Q8(R2), Q11 and Q12 — QbD, design space, control strategy, Established Conditions and PACMPs. The QbD-to-lifecycle toolkit FDA, EMA and PMDA expect.
Plain-English guide to Regulation (EU) 2024/1689 — risk tiers, high-risk AI obligations, GMLP, PCCPs, and how the AI Act stacks on Annex 11, 21 CFR Part 11, GAMP 5, CSA and ICH Q9.
Spin up a workspace seeded for Radiopharma.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
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