Licenses & Certifications
TruoX Laboratories is building a compliant, audit-ready operation from first principles.
This page summarizes our current status and the licenses, registrations, and standards we are aligning to as we scale.
Current Status
TruoX is in a pre-operational (pre-MVP) stage. Our proprietary TruoX LIMS and CSV suite are being developed and validated in line with GAMP 5 (2nd Ed.) and 21 CFR Part 11 to ensure readiness for regulated use.
All validation deliverables (VP, URS/FRS/SDS, RTM, IQ/OQ/PQ) are version-controlled and traceable.
Regulatory Frameworks & Standards (Operating Basis)
- Health Canada GMP (C.02.001–C.02.029) — Personnel, premises, equipment, documentation, testing, and records.
- ICH Q7–Q10 — Quality system and risk-based control strategy.
- GAMP 5 (2nd Edition) — Validation of computerized systems.
- 21 CFR Part 11 (applicability awareness) — Electronic records and signatures.
- ALCOA+ — Data integrity principles.
- ISO 9001 / ISO 14001 (planned certification) — Quality & environmental management.
- CEPA / CNESST / EQA — Environmental and occupational compliance.
Licences & Registrations by Phase
| Phase | Licence / Registration | Notes & Scope |
|---|---|---|
| MVP (pre-ops) | None required for external testing | Building validated digital infrastructure (LIMS/CSV) only. |
| Phase I – QC Laboratory | Drug Establishment Licence (DEL) – Tester | Health Canada DEL authorizes testing activities for finished products/APIs as applicable. Site, activities, and categories (e.g., sterile/non-sterile) defined in the DEL. |
| Establishment listings (where applicable) | Any local permits (municipal occupancy, waste, etc.) aligned to lab operations. | |
| Phase II – SaaS (TruoX LIMS) | QMS for software operations | GAMP 5 lifecycle, supplier qualification, service controls; ISO 9001 targeted. |
| Phase III – Contract Manufacturing | DEL – Fabricator / Packager-Labeller / Importer / Distributor / Wholesaler (as applicable) | Specific DEL activities added per manufacturing scope; may require MDEL-adjacent considerations for devices used in scope and import controls if applicable. |
| Phase IV – Generics | DIN submissions (drug identification numbers) & updated DEL scope | RA submissions (CMC/quality modules), pharmacovigilance systems, and expanded GMP compliance. |
| Phase V – Biomanufacturing | BRDD engagement & expanded DEL scope | Biosimilars/bioprocess licensing pathways; additional biologics-specific GMP expectations. |
DEL context: In Canada, a Drug Establishment Licence is required for regulated activities including testing, fabrication, packaging/labelling, importation, distribution, and wholesale. For TruoX’s analytical lab, the initial authorization target is DEL – Tester; future phases add activities as scope expands.
Supporting Compliance Controls
- Quality Management System (QMS): SOPs, controlled templates, deviation/CAPA, change control, internal audits, and management review.
- Computerized System Validation (CSV): Risk-based lifecycle (URS → FRS/SDS → IQ/OQ/PQ) with traceability to requirements and data-integrity controls.
- Data & Records: Part 11-aligned controls for audit trail, e-sign, access, backup/restore,