The modules
Every module carries the maturity label our engineers use internally — you'd find out by week two anyway.
Deepest-built; where daily work happens today
Complete core workflows in production shape
Functional; maturing with design partners
Foundation shipped; workflows expanding
Committed, not yet shipped
Plan, execute, sign and close supplier and internal audits — from evidence to e-signed closure certificate.
Versioned, approval-gated documents with AI classification and review reminders.
Finding to effectiveness check — owners, due dates and an e-signature at every gate.
One supplier inbox, section assignment, no-login responses, 12-dimension risk snapshots.
Cited regulatory Q&A across 11 standards, persona-aware playbooks, e-signature-gated execution.
Change requests with approval gates, impact assessment and training auto-assignment.
Risk registers wired to audits, CAPAs and suppliers.
Equipment records, qualification states and maintenance trails.
Custody transfers with tamper-evident hand-off records.
Structured review queues for regulated transactions.
openFDA, EDQM and EudraGMDP signals inside your workflows.
Intake, AI classification and disposition drafting with CAPA recommendations.
Assignments driven by role and by change control.
MRM packs assembled from live module data, e-signed.
Quality-gated sourcing wired to supplier qualification.
Enable Supplier Quality and CAPA, Deviation and Audit come with it — the workflows genuinely connect.