Secure AI Agent · Pharmaceutical
AI applied to
quality and regulatory work
A specialist configured to prepare deviations and CAPA, organize batch record review, and track pharmacovigilance deadlines. The qualified person signs; the agent prepares and chases.
Companies that trust UPX
Capabilities
What the Pharmaceutical Agent
can do
Main areas of work for the Pharmaceutical Manufacturing AI Agent in your operation.
Deviation records
Structures the deviation report with the context the investigation needs.
CAPA tracking
Monitors corrective and preventive actions, with owner and deadline.
Batch record review
Checks documentation completeness before the qualified person's analysis.
Pharmacovigilance deadlines
Flags the regulatory reporting deadlines that are running.
Change control
Organizes change control with impact, approvals, and evidence.
Inspection readiness
Gathers the documentation regulators typically request during inspection.
Skills
Capabilities that compose the specialist
Skills add specific capabilities to the Secure AI Agent according to the processes it needs to execute.
- Deviation structuring
- Organizes the report and gathers context for the investigation.
- Document check
- Verifies batch record completeness before review.
- Deadline control
- Tracks regulatory due dates and alerts the owners.
How it worksFrom deviation to release,
From deviation to release,
with review at every step
Connect your document sources, define what the agent can do, and let preparation happen within your quality system's limits.
- Connect documentation and ERP
- The agent works with what quality already records.Connect the document base, the ERP, and the communication channels so the Secure AI Agent has access only to what it needs to prepare each dossier.
- Ask for the work
- Talk to the agent in natural language.Request the CAPA status, a batch record check, or the reporting deadlines through the available channels. The agent understands the context, applies the configured skills, and follows your company's procedures.
- The agent prepares. The QP signs.
- From preparation to release, with control.The agent checks, organizes, and chases within the defined permissions. Batch release, CAPA approval, and regulatory reporting stay with the qualified person and the quality team.
01
02
03
Integrations
Connected to the sources where quality already records
The Pharmaceutical Manufacturing AI Agent can query your documentation and run tasks in the systems your team already uses.
Flow
What goes in,
what the agent does, and what comes out
From the raw record to a checked dossier, following your company's procedures and permissions.
Inputs
- Batch recordPDF
- Deviation reportDOC
- CAPA planCSV
Processing
Secure AI Agent
Processing the task
- Read
- Check
- Cross-checkrunning
- Prepare
Skill appliedProcedure verified
Output
Completed
Dossier prepared
- Documentation gaps flagged
- CAPA deadlines highlighted
- Ready for QP review
Control
You define how far the Agent can act
Different actions can operate with different autonomy levels, always within your company's procedures.
- 1
Query
Reads documents and records and answers with the reference.
- 2
Prepare
Checks completeness and organizes the dossier.
- 3
Request review
Waits for validation from the qualified person.
- 4
Execute
Performs the action within the defined limits.
Levels are configured per type of action, according to each company's quality system. Batch release, CAPA approval, and regulatory reporting always stay with the qualified person.
Get started
Put a Secure AI Agent to work.
Start on the platform or choose the plan that fits the pace of your operation.
Security and compliance
Security that can be verified.
Certifications and attestations
UPX maintains SOC 2 Type II and ISO 27001, with independent audit over its information security controls.
Privacy and regulation
- LGPD
- Operations follow Brazil's Law 13.709/2018. In AI Agent contracts, UPX acts as data processor; the legal basis remains with your company.
- Zero Data Retention
- A product policy, not a certification: with compatible providers and configurations, processed content is not retained after execution.
- Retention and deletion
- The retention policy is defined by contract. Once the contract ends, data is deleted within the agreed period.
Frequently asked questions
Common questions about the Pharmaceutical Agent
What quality teams usually ask before putting an agent to support the regulatory routine.
Does the agent release batches?
No. Release is reserved for the qualified person. The agent checks documentation completeness, flags gaps, and leaves the dossier ready for the analysis of whoever signs.Does it replace our validated system?
No. Official records stay in the systems that already meet validation requirements. The agent works on organizing, checking, and chasing deadlines, without becoming the system of record.Does it report to the regulator for us?
No. The agent tracks pharmacovigilance deadlines and alerts the owners in advance. The submission itself is still made by the authorized person.How does it handle deviation investigations?
The agent structures the report, gathers related records, and organizes the history of similar occurrences. Root cause analysis and the conclusion stay with the quality team.Is our batch data used to train models?
No. Content processed by Secure AI Agents is not used to train UPX models or third-party models.Can we audit what the agent did?
Yes. Every action is logged: what was queried, what was proposed, when, in which system, and under which permission. The history stays available for review and auditing.How long does it take to go live?
It depends on where the documentation lives and on your current procedures. The starting point is connecting the document base and configuring the agent for the routine that consumes most of quality's time.
Secure AI Agent
Bring a Secure AI Agent to your quality operation
Talk to our specialists and see how to adapt this AI Agent to your processes, systems, and needs.