Order 4471: please confirm delivery date
Agents for everything in pharma that has to be traceable.
Friday lunchtime in quality assurance. Production has raised a deviation on a batch. Before anyone can classify it, the batch records have to be pulled together from three systems. Meanwhile, an adverse event report from a doctor is sitting in the fax tray, and Medical Information is waiting to approve a response that has been in drafting since Tuesday. In pharma and healthcare, everything has to be documented and traceable. The work is done to a high standard, but it also takes a long time. We would like to change that.
Done
Awaiting approvalApproval by a colleague
Log
Where your time goes today
A deviation in production isn't classified until days later, because the QA colleague first has to gather the batch records from the MES, the LIMS and the paper file.
Adverse event reports come in by email, fax and phone note, and every one is entered into the safety database by hand.
Doctors are waiting for answers on dosing and interactions, and every piece of wording goes through approval on its own.
Six processes an agent can take on here
Each one sets out what comes in, what the agent checks, what goes out and when a person has the final say. Your own process will have its quirks, and that is the one we want to hear about.
Classify a deviation and suggest root causes
IntakeA deviation report from production, with the batch and process step and a description of what differed from the plan.
DecisionThe agent gathers the batch records, equipment data and similar past deviations, then suggests a classification and possible root causes.
ResultA pre-filled deviation report in the QMS with a suggested classification and references to similar earlier cases.
Capture and assess an adverse event report
IntakeA report from a doctor, a patient or a partner company, by email, form or phone note.
DecisionThe agent extracts the minimum criteria, checks completeness and seriousness, and recognises whether the case has been reported before.
ResultA complete case in the safety database with a suggested assessment and a draft follow-up request.
Answer a medical information enquiry
IntakeA question from a doctor or pharmacist about dosing, interactions or the clinical evidence.
DecisionThe agent searches your approved standard responses, the summary of product characteristics and the literature, and recognises whether a standard response answers the question.
ResultA draft response with references and a note of the standard response it used.
Check supplier certificates and keep qualification up to date
IntakeA GMP certificate, audit report or declaration of conformity from a raw material supplier, sent as a PDF and usually just before the old one expires.
DecisionThe agent checks the document type, validity and scope against your supplier file and recognises whether the qualification still holds or an audit is due.
ResultAn updated supplier file in the QMS with a suggested status and a draft request to the supplier.
Respond to a request for a certificate of analysis
IntakeA customer or wholesaler emails asking for the certificate of analysis for a batch. The batch number often comes from a photo of the packaging.
DecisionThe agent identifies the batch and checks that the certificate has been released and that the requester actually received that batch.
ResultA draft reply with the correct certificate, or a note to sales explaining why the request isn't straightforward.
Check training records
IntakeA list of GMP training that is due, from the learning management system, or an employee's training certificate as a PDF or scan.
DecisionThe agent checks the certificate against the training plan for the role and checks the due dates. It identifies who would currently no longer be qualified for which task.
ResultAn updated training record and an overview for the head of department, plus draft reminders to the people concerned.
Your process is not on the list?
Then it is probably the more interesting one. Use our Process Check to describe what piles up every week in three sentences, and we will tell you honestly whether an agent could take it on.
Answer a medical information enquiry
We would start with medical information enquiries. The answers draw on texts you have already approved, which keeps validation manageable. Your team will see the difference in response times in the first week, and so will the doctors.
Our target3 daysfaster classification of deviations is the aim, because the records and comparable cases are already gathered when the report comes in.
Agentreads
Done09:41
Awaiting approvalApproval by a colleague
Log
What the agent needs
The agent needs batch and equipment data from the MES and LIMS, documents from the QMS and DMS, cases from the safety database and access to the departmental inboxes. We hold this data in Microsoft Fabric with versioning and Purview classification, so every step the agent takes refers to a version of the data you can evidence later.
Typical systems in your industry
SAP S/4HANAVeeva VaultLIMS (LabWare, STARLIMS)MES (Körber Werum PAS-X)Argus SafetyMicrosoft 365
What it looks like in practice
Questions pharma and healthcare companies ask us
Does the agent need to be validated under GxP?
Yes, as soon as it plays a part in GxP-relevant decisions. That is why we recommend processes where the agent prepares and a person decides. We provide documentation and logs in a form that fits your validation.
How does the agent handle patient data?
The data stays in your Azure tenant in the EU. Purview labels health data, and the agent only gets the fields its case needs, not the whole record. Every access is logged.
Can we fix the model version?
You can pin it, but you can't freeze it forever. In Microsoft Foundry, we pin the model version and switch off automatic upgrades, so any change is a deliberate decision with testing and approval. There are no silent overnight updates. Microsoft gives advance notice when a version is retired, and we plan the switch with you within that window, including a regression test with real cases from your log.
What happens with Veeva and our validation documents?
The agent reads and suggests, nothing more. It does not touch approved documents. Anything that has to be written goes through the workflows you have already validated.
What challenge is your business facing?
Your challenge is what interests us most. Send us a few lines about it. We will look at it free of charge, based on the systems you use today, and tell you honestly whether an agent is worth it.
