How it works
From signup to signed audit — in a single afternoon.
BioTrace replaces a stack of validated tools with one system that's compliant from the first click.
1. Set up your organization
Sign up, name your organization, invite teammates with role-based access (QA, RA, Manufacturing, Clinical), and pick the regulatory frameworks that apply to you (FDA, EMA, ISO 13485, GxP).
2. Bring in your existing records
Import SOPs, supplier lists, equipment, and historical deviations. Every record gets a stable ID and lands inside the audit-grade trail from day one — no spreadsheets left behind.
3. Operate with cryptographic accountability
Every create, update, approval, and electronic signature is appended to an immutable log with before/after snapshots, IP capture, and signature meaning — exactly what 21 CFR Part 11 requires.
4. Walk into inspections ready
Continuous compliance scoring surfaces gaps before auditors do. When the inspector arrives, open the war-room and pull signed audit reports, training records, and CAPA effectiveness in seconds.