Traceability gap agent
Finds requirements without verification evidence and risks without controls, and lists them for engineers.
Human approval before any system of record changes
Life sciences · Life Sciences
Design history and change control that stand up to scrutiny.
For medical device and life sciences companies, we connect design, quality and regulatory data so traceability is built in, not bolted on.
Industry challenges
What holds Life Sciences operations back.
Challenge 01
Design history assembled by hand
Design history files are compiled from scattered documents just before submissions and audits.
Challenge 02
Fragile traceability
Linking requirements, risks, verification and changes is manual and breaks easily.
Challenge 03
Many markets, many submissions
Each market has its own regulatory requirements, multiplying the documentation effort.
How we help
Four practices, applied to how your industry really works.
Engage one practice or the full journey. The same team carries the work from diagnosis to agents in production.
- 01 · DiagnoseStrategy
Operations & Data Diagnostics
Assess design control, risk management and traceability maturity.
Explore the practice - 02 · ArchitectRoadmap
Technology Landscape & Process Engineering
Design the landscape linking PLM, QMS and regulatory information systems.
Explore the practice - 03 · ImplementDelivery
PLM & ERP Implementation
Teamcenter or 3DEXPERIENCE for design control and change, implemented on validated processes.
Explore the practice - 04 · AutomateAgentic AI
AI Agents & Process Automation
Agents that find traceability gaps and prepare submission document sets.
Explore the practice
AI agents
Agents built for Life Sciences work.
Examples of the agents we design for this industry. Each one works inside your systems and hands decisions to a named person for approval.
Submission pack agent
Gathers and checks the documents needed for a regulatory submission against the market's checklist.
Human approval before any system of record changes
More industries
From under the sea to the sky.
Healthcare
Healthcare
Supply, asset and inventory flows across providers, with traceability built in.
WellnessAyurvedic Wellness
Classical formulations, herb sourcing, batch records and AYUSH compliance.
ConsumerFMCG
Recipe and pack management, artwork approval and rapid SKU launches.
ConsumerRetail
Private label development, assortment planning and supplier collaboration.
Start a conversation
Talk to a partner who knows Life Sciences.
Share where your operations are stuck and a partner will come back with a working view of what to do first. No sales script.