Where crews start
Workflows we take to production
Deviation and CAPA investigation
Drafts investigation reports from batch records, deviations and trend data for QA to approve.
Measured: days to close, overdue investigations
Supply-chain exception handling
Watches supplier commitments, shortages and expiries, and drafts the mitigation for planners.
Measured: shortages caught early, planner hours
Regulatory document drafting
First drafts of CMC sections, change notifications and responses, linked to source data.
Measured: authoring hours, review cycles
Medical information support
Responses to inquiries grounded in approved labeling and standard response documents.
Measured: turnaround, consistency
What we're seeing
Pharma and medical-device companies have opened FDE and AI-enablement roles in IT, supply management and R&D, and many are also hiring new heads of AI.
How we work in pharma & medical devices
- Computer system validation (CSV/CSA) documentation included
- 21 CFR Part 11-aware audit trails and e-signatures
- Human review on every regulated output
How to start
- Recon: 2 weeks to rank your workflows and prototype the top pick
- Sortie: 6–8 weeks to put one workflow into production
- Bridge: cover your open FDE seat until your hire is ramped