New: AI‑powered compliance

TraceCert AI COA & Regulatory Report Generator

Generate audit‑ready Certificates of Analysis and regulatory reports in minutes. Ingest data from LIMS/ERP, auto‑validate against specs, and export compliant PDFs and machine‑readable files for FDA, EU MDR, ISO, REACH, RoHS, and more.

From raw data to signed COA—fast, traceable, compliant

Generate audit‑ready COAs and regulatory reports in minutes

One‑click COA and report generation

Controlled templates for USP/EP/ICH and custom specs auto‑populate from LIMS/ELN/ERP. Built‑in calculations, unit normalization, and OOS checks ensure accuracy before release.

End‑to‑end traceability and review

Full audit trail with data lineage back to instruments and methods. Redlined revisions, reviewer checklists, and 21 CFR Part 11/Annex 11 e‑signatures make every change inspectable.

On‑time, compliant workflows

SLA timers, stage gates, and reminders keep drafting, review, and approval on schedule. Expiry tracking and controlled re‑issue ensure continuous regulatory readiness.

Frequently asked questions

Be audit‑ready—every batch, every release

Automate COAs and regulatory submissions with templates, rules, and AI validation. Eliminate copy‑paste, ensure traceability, capture 21 CFR Part 11 e‑signatures, and ship compliant docs faster.