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simpl.bio

Life-Sciences eQMS

GxP quality management for biotech & pharma

Overview

simpl.bio is a life-sciences eQMS covering the full GxP landscape — from cGMP manufacturing to clinical and laboratory practice. It unifies controlled documents, training records, deviations, change control, and CAPA, with Part 11–ready electronic signatures and audit trails throughout. Its defining strength is CRO and vendor oversight: the work you outsource stays inside your quality system.

What sets it apart

CRO & vendor oversight inside your quality system

Capabilities

Controlled document & SOP lifecycle with e-signatures
Training matrix tied to role and document revision
Deviations, CAPA, and change control workflows
CRO / contract-lab oversight and qualification
Part 11 audit trails on every record
Inspection-ready PDF export across all modules