Gap analysis ready
Audit-ready
Audit Readiness Check
AGENTIC
Awaiting approval
DONE
WAITING ON YOU
PENDING
1
Pull active records across QMS modules
Iris scans procedures, DHF, training, supplier files, and CAPA history
2
Map clauses to ISO 13485 requirements
Trace every clause to its evidence, training records, and CAPA history
3
Author review
APPROVAL GATE
Sarah Chen reviews the gap analysis before next step
4
Draft remediation playbook
Iris proposes specific actions for each flagged gap
5
QA + RA dual sign-off
APPROVAL GATE
Both leads sign before any change is published
THE AGENTIC PLATFORM FOR REGULATED PRODUCT DEVELOPMENT
AI does the work.
You stay in control.
Today: an agentic QMS for MedTech. Tomorrow: the operating system for life sciences — ALM, PLM, MES, RIM, and more.
∞
Agentic workflows
built by us — and by you
built by us — and by you
Human in the loop.
Every step.
Every step.
30 days
Typical deployment
with validation
with validation
THE PLATFORM
QMS today.
The operating system
for life sciences, on the way.
Most companies stitch together a quality system, an ALM tool, a PLM tool, a manufacturing system, a regulatory tracker — five vendors, five integrations, five audit trails. Syneris is rebuilding the regulated stack from the ground up. Quality ships today. The rest is on the way.
Not five tools. One platform.
Available today
QMS
Quality Management
The full quality system, AI-native from the foundation. Every module with Iris built in, not bolted on.
Documents
Changes
Training
Audits
CAPA / NCR / SCAR
Suppliers
Equipment
Standards Library
On the roadmap
ALM
Application Lifecycle
Design Control, Requirements, Risk Management, V&V, Human Factors.
PLM
Product Lifecycle
BOM, Engineering Change, Configurations, CAD links.
MES
Manufacturing Execution
eDMR, eDHR, Work Orders, Lot Tracking, Inventory, Calibration.
RIM
Regulatory Information
Submissions, Reg Intelligence, Post-Market Surveillance, Adverse Event Reporting.
Clinical Operations · CRM · ERP · CAD · whatever the regulated lifecycle needs next.
Iris drafts.
From regulation to policy. From scope to plan. From input to output. Iris turns the work that takes hours into review-ready drafts in minutes — across every document that lives in your QMS.
Always cited. Every Iris draft references its sources — clauses, prior decisions, linked records. Always reviewable. Nothing publishes without your sign-off.
Iris executes.
Multi-step workflows that span modules, run in the background, and pause at human gates. Iris plans, executes, waits for review, and resumes — never silently, never alone.
Always gated. Every consequential step waits for a named approver. Always logged. Every action lands in your 21 CFR Part 11 audit trail alongside human actions.
Iris watches.
Always-on awareness of what's changing — in your records and in the regulatory landscape. When something shifts, Iris finds what it touches and tells you what to do next.
Always proactive. Iris flags before things break. Always optional. Tune what she watches and how often she speaks up.
An agentic teammate
for QA, RA, and R&D.
Iris isn't a chatbot bolted onto a legacy QMS. Iris is a generative + agentic AI built into every Syneris module — able to draft, compare, trace, and execute multi-step workflows with explicit approval gates at every consequential turn.
HUMAN IN THE LOOP · ALWAYS
AI velocity. Human accountability. Both, by design.
Approval gates
Nothing publishes without your signature. Configurable by role.
Audit trail
Every Iris action e-signed alongside human actions. 21 CFR Part 11 native.
Cited reasoning
Every recommendation links to its sources. No black box, no surprises.
Override & rollback
Reject anything. Roll back everything. Iris defers to human judgment.
See Iris run a real workflow on your QMS.
See Iris in action on a workflow that matches your real challenges.