AI workflows that behave like quality systems. Not prototypes.
We build traceable AI for postmarket, investigations, and quality documentation. Outputs are reviewed when needed and monitored in production.
Governed AI means
Governed AI means AI with audit logs, review steps, and monitoring.
- Outputs link back to sources when possible
- High-risk steps require human approval
- Quality is measured over time, not assumed
Where we help
- Complaint intake and classification support
- Investigation and CAPA narrative drafting support
- Postmarket surveillance summarization
- Supplier quality documentation workflows
- Consistency checks and exception handling
Example output: investigation and CAPA drafting support with evidence links and reviewer checkpoints.
What you get
Inputs include complaint records, investigation notes, and quality documentation. Outputs include controlled drafts, audit logs, and reviewer queues. Impact: faster throughput with fewer inconsistencies.
- Controlled prompts/workflows with documented behavior
- Audit trails and reviewer queues
- Evaluation harness + ongoing monitoring
- Deployment in your environment (VPC or on prem as needed)
Proof
Case study (anonymized): postmarket surveillance summaries and CAPA drafting with traceable evidence.
Build something that passes scrutiny
Scope a pilot quickly and ship into production with governance built in.