Agentic Deviation Solver
An AI deputy for your QA team.
Helps QA reviewers draft deviation investigations, CAPA plans, and form extractions in minutes, without taking the pen out of your hand. Every AI output stays advisory until your reviewer approves.
Built by AXUM AI Partners · devisolve.com
Watch
The case for DeviSolve.
Why current tools fail
Old QMS gives you forms. It doesn't think.
Paper batch records
Operators write on pre-printed forms. Corrections are strikethrough plus initials plus 2-letter code. Nothing is searchable until someone retypes it.
Copy-paste investigations
Every deviation report is rewritten from a Word template. Past root-cause analyses sit in PDFs nobody reads.
SOPs nobody can search
Drafting an investigation means opening 5 PDFs and Ctrl-F'ing for 'temperature.'
The product
Four AI agents, one closed loop.
Each agent searches your SOPs and prior deviations. Every output is a draft your reviewer accepts, edits, or rejects.
Intake and Triage
Classifies a new deviation: severity (Critical, Major, or Minor), category, and a 1-10 risk score. Pulls from your SOPs and 8 most-similar past deviations.
Compliance Context
Retrieves the governing SOP (current approved version), associated forms, and historical investigations relevant to this event, feeding everything else.
Investigation Drafting
Drafts a 6-section investigation: event summary, immediate correction, investigation, root cause, product impact, CAPA decision. Cites sources.
CAPA Drafting
Drafts corrective and preventive actions, identifies SOP changes needed, flags training-impact, and proposes action items with realistic timelines.
Pilot program
Evaluate DeviSolve on your real workflows.
Step 1
Onboard
Ingest your SOPs. Map your form templates. Migrate the last 12 months of deviations and CAPAs.
Step 2
Run
QA processes 5 to 10 active deviations through the AI pipeline. Side-by-side review against your current process.
Step 3
Measure
Read out cycle-time reduction and AI-acceptance rate. Decide: continue, expand, or stop.
Who built this
Quality leaders plus AI builders, working as one team.
Bogdan Hriscanu
Biopharma Supply Chain & cGMP Operations Lead
Supply chain and S&OP leader with biopharma logistics, cGMP planning, procurement, inventory, and global trade-flow experience. Shapes DeviSolve around the operating realities of regulated manufacturing, audit readiness, and quality-driven execution.
Theodora Miller
Quality Assurance & Technical Transfer Lead
Quality assurance executive and technical expert with experience across technical transfer and regulated health-sector operations. Brings the reviewer’s lens to DeviSolve: documentation discipline, inspection readiness, and practical QA workflows that hold up under regulatory scrutiny.
Anand Chhatpar
AI Engineering Lead
Audit-trail and access-control patterns informed by 21 CFR Part 11 conventions. Built the AI drafting layer. Eight patents in product engineering and twenty years of shipping production systems.
One team under AXUM AI Partners. Not a generic LLM wrapper. Not a regulatory consultancy with no software.
Let's talk
Run the demo on your own data.
Tell us about your QMS shape (what eQMS you're on today, the friction you're trying to solve). After NDA/DPA we'll send you a secure upload link for any sample documents — please do not email regulated GxP records, SOPs, or deviation files.
DeviSolve. An AI deputy for your QA team. Built by AXUM AI Partners.