1
Establish the QMS
Define processes, determine applicable requirements, set scope and systems in scope, publish policy, assign authorities, and plan quality objectives.
Operating model
From first registration to post-market control
A practical path teams follow in the platform. Exact procedures stay yours; the system supplies structure, gates, and evidence hooks at each step.
2
Register each AI system
Create the system identity with intended purpose and version. This identity becomes the traceability key for all later records.
3
Classify and assess risk
Record the risk classification decision, open the risk management file and cybersecurity framework, and establish residual risk criteria.
4
Realise the system
Drive lifecycle stages, design and data activities, supplier controls, verification and validation, and technical documentation assembly.
5
Release with control
Complete release evidence, instructions for use, logging and oversight readiness, and conformity pathway records before placing on the market.
6
Operate and monitor
Maintain deployment and version control, human oversight, support services, post-market monitoring, and incident / CAPA handling.
7
Change deliberately
Route modifications through change control; re-evaluate risk and documentation; trigger re-assessment when modifications are substantial.
8
Evaluate and improve
Run internal audits and management review, retain records for the required period, and feed lessons into continual improvement.
What users see on controlled work
Consistent patterns reduce training time and strengthen auditability.
AI context banner
System identifier, reference, intended purpose, and version stay visible while editing records.
Requirement-led tabs
Structured fields follow regulatory and standards language so mandatory content is harder to skip.
Control actions
From a record, initiate change, nonconformity, evidence export, or review — without losing source context.
Walk through the lifecycle on your data
Request a demonstration using one of your AI systems as the narrative thread.