Industries / Pharma & Healthcare
Pharma & Healthcare
Batch records that
answer the auditor.
Batch records, validation protocols, deviations and CAPAs — cross-referenced in one query, cited to the section.
A day with BodhAI
Follow a QA lead through audit week.
09:00 · Audit prep
QA lead
Every deviation on Line 3 granulation in the last 12 months, with CAPA status.
BODHAI
Four deviations. Three CAPAs closed with effectiveness checks; DEV-2026-08 open — effectiveness review due 12 Jul.📄 Deviation_Log📊 CAPA_Tracker
12:30 · Batch release
Qualified Person
Does BR-2026-114 meet every spec in the validation protocol?
BODHAI
All 14 CQAs within limits. Granule hold time 68h — inside the validated 72h window at ≤25°C / ≤60% RH.📄 BR-2026-114📄 VP-GR-004 §7.1
15:00 · Regulator query
Regulatory affairs
Draft the response annex: stability summary for 25°C/60%RH.
BODHAI
Annex drafted from the last three stability studies, tables included, every figure cited.DOCX
Stability_Annex_Draft.docx
generated · 3 studies cited
Where BodhAI sits
Stage-gates stay. Searching for evidence goes.
Batch record
QA
Validation
QP
Release
BodhAI
evidence for every gate, cited
12 mo
deviations · 1 query
14
CQAs cross-checked
100%
on-premise
5 min
install