Quality events
Deviations, CAPA and change control linked to the batches they affect.
AI reads batch books and supplier paperwork, spots recurring deviations and plans materials, with QA signing every decision. Keep material status, dispensing, batch steps, lab results and packaging on one record, so your authorised person reviews a complete batch rather than chasing paper.
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Five reasons not to put it off.
Paper batch records hide errors.
A skipped signature or wrong material lot stays buried until batch review or inspection.
Add warehouse and quality when you're ready.
Sampled lots move from quarantine to released, and only released lots can be picked.
Scan the lot, weigh to target and see the tolerance at the balance.
Operators follow the approved instructions; each stage is signed and reviewed.
Labels and packaging components are counted and reconciled against the batch.
Your authorised person reviews the complete record and records the decision.
Each record stays linked by lot, for example API-77310 → RM-5120 → T-2406 → SHP-8812. People make the quality and release decisions; V5 keeps the evidence together. See inventory & traceability
It predicts and flags. Fixed rules decide. People sign.
Predicts demand before it hits.
Forecasts demand and tunes API and excipient reorder points.
Quality, the lab, equipment and suppliers share one system with your batches.
Deviations, CAPA and change control linked to the batches they affect.
Samples, results and stability studies in the same system as the batch.
Know which rooms and machines are clean, calibrated and serviced.
Approved suppliers, current instructions and trained people behind every batch.



Right material. Right record. Released by a person.
33 pages · 4 worksheets · 16 primary sources
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Reviewing a supplier for GxP records? See backup, recovery and resilience and the security procurement reference.
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