Evidence-driven deviation investigations
Timeline reconstruction, gap analysis, a root cause workbench, CAPA options, and an FDA/GMP risk checker — with readiness and quality scores before QA review.
Explore WorkbenchSolutions Pharma & CDMO
Pharmaceutical & CDMOAI copilots for pharma & CDMO quality.
Close deviations faster, strengthen CAPA, and bring consistent investigation quality across every internal site and external partner — without compromising GMP discipline.
Deviations
CAPA
GMP
21 CFR Part 11
CDMO oversight
The challenge
Investigations decide your inspection outcome.
In pharma and CDMO operations, the quality of a deviation investigation is the quality of your audit trail. The pressure is speed and rigor — at the same time.
Deviation backlogs delaying batch disposition
Inconsistent quality across CDMO & partner sites
Repeat deviations from ineffective CAPA
483 / inspection exposure on weak RCA
Data integrity & 21 CFR Part 11 expectations
“Human error” closures that mask systemic causes
The result: investigations become documentation exercises — not decisions.
How we help
Three copilots, mapped to pharma & CDMO.
Systemic RCA & CAPA effectiveness
Coaches investigators past first answers into true root cause — strengthening 5-Why and Fishbone thinking so CAPAs actually prevent recurrence.
Explore A3 CoachCross-site improvement events
Plan and run focused Kaizen events to standardize investigation practice across sites and CDMOs, with control plans that sustain the gains.
Explore Kaizen Copilot
Regulated by default
Built for environments where the audit trail is the product.
Full audit trails, deterministic boundaries, and data security aligned with GMP and FDA 21 CFR Part 11 principles. AI supports structure, evidence review, and decision quality — human judgment and authorized QMS approval stay central.
Pricing
Start on anonymized deviations.
Start with sample or anonymized investigations and get a readiness and quality baseline in weeks, not quarters.