Built for compliant, audit‑ready output
Features that keep COAs and regulatory reports accurate and on time
Rapid, consistent generation
Produce standardized COAs and regulatory summaries in minutes using smart templates. Enforce sections, units, specs, and naming for consistent, audit‑ready deliverables every time.
End‑to‑end traceability
Every value is linked to its source data, method, and timestamp. Review evidence, change history, and approvals in one place for full line‑of‑sight during review and release.
Automated checks and exports
Auto‑validate calculations, limits, and signatures before release. Export to PDF/Word/JSON and hand off via secure links or integrations to your existing LIMS/QMS/ERP.
Simple Pricing
Flexible pricing to match any budget or team size.
Starting at
14-day free trial — no credit card required.
Everything you need to generate compliant, audit-ready COAs and regulatory reports
- Generate COAs and regulatory reports in minutes from your lab data
- Prebuilt templates for FDA, EMA/ICH, ISO 17025, and GMP — fully brandable
- 21 CFR Part 11-compliant e-signatures and complete audit trails
- LIMS/ELN and instrument data integrations, plus REST API and webhooks
- Automated calculations, specification checks, and OOS/OOT flagging
- Review, approval, and version control with role-based permissions
- Data lineage and immutable change history for end-to-end traceability
- Batch generation, scheduling, and rules-based template selection
- Multi-language output and unit conversions
- Export to PDF, DOCX, and machine-readable JSON/CSV
- Attach evidence (chromatograms, certificates, methods, raw files)
- SSO/SCIM, RBAC, IP allowlisting, and granular access controls
- Security: SOC 2 Type II, encryption at rest and in transit
- Validation package, sandbox, and audit-ready documentation
- Standard support with 99.9% uptime SLA; priority support add-on
Frequently asked questions
Audit-ready documents, on autopilot.
Plug into your LIMS/ERP, pick a template, and let TraceCert AI produce compliant COAs and filings with traceability, version control, and Part 11-ready e-signatures.