FDA · EMA · ISO · GxP
Regulatory compliance,
fully traceable.
One auditable system for biotech, pharma, medical device, CRO, and academic teams. Manage regulations, audits, deviations, CAPAs, trials, manufacturing, and submissions — with cryptographic audit trails by default.
Multi-framework
FDA, EMA, ISO 13485/9001, GMP, GLP, GCP coverage.
Audit-grade trail
Append-only logs with before/after snapshots on every change.
Inspection-ready
Continuous readiness scoring and gap remediation workflows.
How it works
From signup to signed audit — in an afternoon.
1. Set up your organization
Sign up, invite teammates, pick the frameworks that apply (FDA, EMA, ISO 13485, GxP).
2. Bring in existing records
Import SOPs, suppliers, equipment, and historical deviations — all stamped into the audit trail.
3. Operate with accountability
Every change captured in an append-only log with electronic signatures and meaning.
4. Walk into inspections ready
Continuous scoring surfaces gaps before auditors do. Pull signed evidence in seconds.
Features
Everything regulated teams need.
One platform for quality, manufacturing, clinical, and submissions.
Audit Management
Plan, execute, and close audits with electronic checklists and signed reports.
Deviations & CAPAs
Risk-scored intake, root-cause investigations, and effectiveness checks.
Controlled Documents
Part 11 SOPs with versioning, multi-stage approval, and electronic signatures.
Training Compliance
Curricula, assignments, and qualification matrices tied to controlled docs.
Manufacturing (GMP)
Batch records, EM, equipment qualifications, change control, and APRs.
Clinical Trials (GCP)
Protocol deviations, IRB approvals, IP accountability, monitoring visits.
Risk Register
Inherent/residual scoring, treatment plans, and trend tracking.
Inspection Readiness
Mock inspections and a live war-room for FDA, EMA, and notified-body visits.
Pricing
Simple, transparent pricing
Every plan includes the audit trail, electronic signatures, and continuous compliance scoring.
Free
Try BioTrace Compliance with full Professional access for 14 days.
- Full Professional access
- All 15 compliance modules
- No credit card required
- Auto-downgrades to Starter after 14 days
Starter
Core quality tools for small teams getting started with compliance.
- Dashboard & compliance scoring
- Regulation library
- Deviation tracker
- CAPA manager
- Up to 3 users
- Up to 1 site
- Email support
Professional
Full compliance platform for growing biotech and pharma teams.
- Everything in Starter
- Audit management
- Controlled document management
- Training & qualification records
- Clinical trial compliance (GCP)
- Manufacturing compliance (GMP)
- ISO compliance tracker
- Electronic logbooks
14-day free trial on Professional · No credit card required to start · See full feature comparison
FAQ
Frequently asked questions
More questions? See the full FAQ or email support@ordex-systems.com.
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