Safety Intake Agent
Identifies valid adverse event cases, extracts the minimum data set and checks for duplicates.
Safety physicians assess causality and seriousness.
Industries · Pharmaceuticals
AI agents for regulatory, safety and quality operations.
Life-sciences teams produce and review enormous volumes of controlled documentation. HonestAI agents prepare, check and route that work under GxP-aware controls — qualified people keep every regulated decision.
The problem
Compliance work scales faster than headcount.
Adverse event reports, regulatory submissions, deviations and SOP updates all require careful reading and cross-checking. Expert time is consumed by assembly and formatting rather than scientific and quality judgement.
- Adverse event intake from many sources
- Submission documents assembled by hand
- Deviation and CAPA records inconsistent
- Medical information requests repetitive
Work we run
The workflows we take on first.
Each one is baselined, scoped with your team and run against an agreed outcome.
- 01Adverse event intake and duplicate checking
- 02Literature screening for safety signals
- 03Regulatory submission section assembly
- 04SOP and controlled document change tracking
- 05Deviation and CAPA documentation
- 06Medical information request drafting
Runs inside the systems you already use
Safety databasesRegulatory information managementQMSDocument managementLIMS
Agents & human control
What agents do. What people decide.
Regulatory Writing Agent
Compiles draft sections from approved sources with full traceability to each reference.
Regulatory leads approve every submission.
Quality Records Agent
Summarises deviations, links prior occurrences and tracks CAPA due dates.
QA approves investigations and closure.
- Validated agent configurations with change control and versioning.
- 21 CFR Part 11-aware audit trails and electronic records handling.
- No regulated decision is made by an agent.
Proof
Related case studies and demos.
Customer results are published only once verified.
Case study · Healthcare
Healthcare Document Intelligence
Documents classified, extracted and routed; staff resolve exceptions only.
Read caseCase study · Cross-industry
Smart DTO Analyzer
Agent cross-checks every record and prepares a discrepancy summary for reviewers.
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AI for document extraction, data structuring, technical file processing and content automation.
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Reduce the documentation burden on your experts.
We'll identify the regulated workflows where agents can safely prepare the work.