Quality & release
Deviations, investigations and the review decision stay with the run they belong to.
AI reads supplier paperwork, spots recurring failed runs and keeps precursors planned, with people authorising every release. Plan each run against its dispatch time, record preparation and QC as they happen, and give your qualified reviewer one connected record before anything leaves.
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Paper can't keep up with decay.
When the clock is running, a missing record or late check costs you the run.
Add warehouse and quality when you're ready.
Photograph the supplier certificate; lot and expiry details are extracted for a person to confirm.
Put each run on the planning board against its dispatch time, so everyone sees the day's sequence.
Follow the approved instructions step by step. Each step records who, what and when.
Results are entered against the run. Anything still outstanding stays clearly visible.
Your qualified reviewer records the decision; the dispatch record links back to the run.
Each record stays linked by lot, for example PK-5521 → RM-2208 → R-0917 → DSP-3310. People make the quality and release decisions; V5 keeps the evidence together. See inventory & traceability
Predicts demand before it hits.
Forecasts dose demand and tunes precursor and consumable reorder points.
Quality, the lab, equipment and planning share one record, so a question about any run has one answer.
Deviations, investigations and the review decision stay with the run they belong to.
Samples, methods and results tied to each run, with trends you can review.
See whether synthesis modules and instruments are calibrated and serviced before the run.
Decay-corrected activity on the records that need it, and the radioactive waste programme in one place.
Runs planned to dispatch times, done by trained people, following current instructions.



Short half-lives. Complete records. Clear decisions.
32-page guide · PDF · 4 worksheets · 12 linked primary sources
How US Part 212, EU Annex 3 and WHO/IAEA guidance treat results that arrive after product leaves, and the wording mistake to avoid.
Supplier qualification, goods-in, status and expiry, master records, the run record, aseptic evidence, labels, trace and transport handover.
Open results, late failures after dispatch, deviations and CAPA, training and independence of the releasing person.
Calibration and maintenance readiness, plus measuring the losses that cost a delivery.
Release procedure, run readiness, a vendor demo checklist and a gap scorecard, plus a phased roadmap.
Practical orientation, not legal advice; your quality unit decides which rules apply.
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Reviewing a supplier for GxP records? See backup, recovery and resilience and the security procurement reference.
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