BayesPK QMS Intelligence OS

Deviation · CAPA · audit · change control · training · data integrity · Part 11 · quality risk · management review

Checking API Program OS
Pharmaceutical Quality System war-room

From QMS events to risk-based CAPA, inspection readiness and management review.

Triage deviations, generate root-cause hypotheses, build CAPA plans, evaluate effectiveness, plan audits, assess change/training/document impact, review supplier quality, perform ALCOA+ data integrity checks, assess Part 11 readiness, and generate a complete executive QMS report.

TriageRisk classify deviation or QMS event
Root Cause5 Whys, fishbone and evidence plan
CAPACorrective, preventive and due dates
IntegrityALCOA+ and Part 11 controls
ReviewQuality risk and management review
--Executive decision
--Quality risk score
--Data integrity risk
--Part 11 readiness

QMS Event Intake

/qms-dashboard

Executive QMS Decision

Awaiting analysis
Run QMS Intelligence to generate deviation risk, root cause, CAPA, DI, Part 11, risk register and management review.

Quality Risk

Compliance Readiness

Final Next Steps

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