Aligned to your specs, SOPs, and regulations
Zero-touch COAs and regulatory reports—end-to-end traceable
One‑click generation
Ingest results from LIMS/instruments, validate against spec limits, merge lot/method metadata, and render branded COAs and regulatory reports in seconds.
Drill‑down traceability
Every value is explainable—tap to see source data, calculations, SOP/version, analyst, instrument status, and chain of custody with a tamper‑evident audit trail (ALCOA+).
Faster review & release
Built‑in QC checks, deviation flags, redlines, and compliant eSignatures speed approval while maintaining 21 CFR Part 11/Annex 11 and ISO/IEC 17025 alignment.
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 go from raw data to audit‑ready COAs
- AI generation of GMP-ready Certificates of Analysis and regulatory summaries from raw instrument files, LIMS exports, or spreadsheets
- Prebuilt templates aligned to FDA/EMA expectations and ICH (e.g., Q2(R2)/Q14), plus USP/EP/JP monograph layouts
- 21 CFR Part 11 e-signatures, complete audit trails, and version control
- Validation assets included (IQ/OQ scripts) with GxP configuration mode
- Reviewer–approver workflows, change control, and redlining
- LIMS/ELN integrations (REST API, SFTP, CSV) with webhook callbacks
- Document extraction for PDFs, chromatograms, and lab reports with structured metadata mapping
- Multilingual COAs (EN, ES, DE, ZH) with controlled vocabulary and glossary management
- Custom templates and branding, headers/footers, and watermarking
- Batch generation and bulk publishing to PDF, DOCX, and machine‑readable XML/JSON
- Role‑based access control (RBAC), SSO/SAML, and SCIM user provisioning
- SOC 2 Type II and ISO 27001–hosted environment with regional data residency options
- Granular retention policies, immutable records, and legal hold
- Priority email support and 99.9% uptime SLA
Frequently asked questions
Turn raw batch data into compliant documents—automatically.
Map once, automate forever. Reduce reporting time by 90% with AI validation, reusable templates, versioning, and e-signatures. Export to PDF, DOCX, and XML; maintain full audit trails; meet 21 CFR Part 11, cGMP, and ISO 17025.