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AI agent for regulatory affairs specialists

Supplier Change Notification Assessment Agent

Each supplier change is assessed and any needed notification is identified in time.

Supplier Change Notification Assessment Agent: what goes in, what the agent does and what you get

What it does

Suppliers send change notices for materials, sites or processes, and each one may require notifying authorities in some markets. These notices are easy to miss. This agent reads supplier notices, links them to products and filings, assesses whether notification is needed in each market and drafts the assessment. It rechecks as supplier data arrives. It decides using the filing records and rules: a change to a registered material or site is likely to need notification. The specialist approves. Edge case: a supplier changes a manufacturing site but the notice does not say which batches, so the agent asks the supplier for the start date.

How it works

Follow the arrows from top to bottom. The orange dashed arrow is the loop: when a check fails, the agent goes back and tries again.

Start and resultWhat it doesA check on its own workWaits for your OKGoes back and retries
ApprovedYes, continueNo 1 STARTS WHEN A supplier notice arrives 2 USES A TOOL Read the notice and identify the change 3 USES A TOOL Find products and filings that use the suppliermaterial or site 4 DOES Compare the change to each market's notificationrules 5 DOES Draft the impact assessment per market 6 DOES List missing information for the supplier 7 YOU APPROVE Specialist approves requests to the supplier 8 USES A TOOL Read the supplier's reply and update the assessment 9 CHECKS THE RESULT Is every market's decision supported by completeinformation? If not: ask the supplier for the missing data andreassess. Back to step 4. 10 RESULT Assessment and notification list
Read the steps as a list
  1. A supplier notice arrives
  2. Read the notice and identify the change
  3. Find products and filings that use the supplier material or site
  4. Compare the change to each market's notification rules
  5. Draft the impact assessment per market
  6. List missing information for the supplier
  7. Specialist approves requests to the supplierThe agent waits here for your OK.
  8. Read the supplier's reply and update the assessment
  9. Is every market's decision supported by complete information?If not: ask the supplier for the missing data and reassess. Back to step 4.
  10. Assessment and notification list

How it decides

It links a change to products by material or site, then compares it with each market's notification rules.

  • Treat a site change as notification-relevant by default
  • Ask for the date the change starts
  • Link by bill of materials, not by product name
  • Note the notification deadline per market

Make it yours

Every agent is a starting point. You choose these settings for your own situation.

  • Notification rules
  • Supplier groups
  • Assessment format
  • Deadlines
  • Request wording

What keeps you in control

It always asks you first

  • Specialist approves supplier requests and the final assessment

Hard limits

  • Never decide a notification is not needed without the rule source
  • Never contact an authority

It stops when

  • Done: every market has a documented decision
  • Stop: the supplier will not provide data

Set it up

We guide you through the set-up, step by step

Members get the full set-up guide for this agent. No technical skills needed: you copy, paste and upload.

10 minto set it up in your AI
5 AIsChatGPT, Claude, Copilot, Gemini, Grok
  • One set of instructions to paste into your AI, with the clicks for ChatGPT, Claude, Microsoft 365 Copilot, Gemini and Grok
  • The agent then walks you through connecting your own data, one source at a time
  • A downloadable copy with the flow chart, the rules and the full guide
Get access to this agent

An example run

What happensA supplier notice announces a new site for an excipient. The agent finds 9 products and 5 markets. It marks 3 markets as notifiable and asks the supplier for the start date. The reply shows the first batch ships in 40 days. On the reassessment, one market requires notification 60 days ahead, so the agent flags it as urgent.

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