Boost the quality and efficiency of your investigators with our investigation AI.
×
A guided method, powered by an AI that supports — never replaces
Polton is built entirely around the Académie de la Qualité efficace’s ELEMENTAIRE approach, already deployed on many pharmaceutical sites.
A guided method, ELEMENTAIRE, beats a toolbox
Supports the investigator, doesn’t do the investigation for them
Independent of historical data
Separate but linked agents
What can Polton do for you?
Polton is an AI that helps handle deviations in the pharmaceutical industry. It works as a companion for the investigator. It doesn’t do the investigation for them, but helps and guides users step by step to improve the Quality and Efficiency of deviation handling.
Collect the right information directly on the shop floor. The companion keeps asking questions until it has a complete, clear 5W2H.
Identify the initial causes. Polton supports the investigator in searching for initial causes using the SCS methodology.
Support the assessment committee in evaluating the risk level and criticality of the event, based on the ICH Q9 risk analysis approach.
Identify the root causes. By applying the cause tree, hypothesis and verification approach, Polton helps the investigator search for root causes.
Manage risks and impacts. Polton helps investigators identify actions to manage risks and impacts.
Polton can propose several types of CAPA and weight them by effectiveness and according to the causes, describing the final deliverable precisely.
Identify recurring causes and topics to improve your activities. Polton doesn’t stop at a simple 5M, but goes into an in-depth analysis.
For every investigation, the report is generated automatically by Polton — no manual formatting needed.
Why not develop it in-house?
The code
The only layer that Claude Code really speeds up, for you as for us.
Software testing and the AI profile
Several hundred tests and a formalised AI profile: expected behaviours, prohibited behaviours, acceptance criteria.
The regulatory file
Validation guidance note, URS, specifications, risk analysis and tests done on our side: your on-site validation is lighter.
The business method
Nearly 10 years of work by two pharmacists on a complete, consistent and effective investigation method, proven on more than 30 sites.
Each layer shapes the next
The method dictated the architecture: one agent per step. Regulatory requirements set the scope: an assistant, the human decides. Tests lock everything in.
Often starts from the top
Code first, validate later. The company becomes its own supplier and, if the author leaves, the GxP tool is orphaned.
Code can be generated.
Ten years of method can’t.
Pricing
No development costs
Depends on the number of deviations per year
Usable immediately with your existing API keys and LLM contracts
Cheaper than 5W2H training for your operators
Watch the webinar replay
Enter your email: you’ll be taken straight to the Polton webinar replay page.
Request a demo
Let’s spend a day comparing investigation methods and testing on several deviations from your site.
Request my demo