Zero Tolerance.
BiQadx is building a quality management infrastructure by design — not by retrospective compliance. This page describes our architecture, frameworks, and validation planning approach across all product development stages.
Design inputs documented. Risk register initiated. Architecture brief drafted.
FMEA active. Design verification planning. DHF structure established.
IQ/OQ protocols drafted. Component-level bench testing. Change control active.
Limited-deployment data collection. Operator training pilot. CAPA system active.
Our QA Architecture
Six quality pillars that govern every product design decision, documented architecture, and validation milestone.
Quality-by-Design (QbD) Approach
BiQadx adopts a quality-by-design philosophy aligned with ICH Q8/Q9/Q10 principles. Design inputs, risk assessments, and verification strategies are embedded from the earliest concept stages — not appended at the end of development. Every architecture decision is documented with a design rationale traceable to the product requirements specification (PRS).
- Design FMEA initiated at Concept stage
- Risk management per ISO 14971 framework direction
- Design history file (DHF) structure prepared
Validation Stage Framework
Validation activities are planned in stages aligned with our product development model. Instrument verification (IQ/OQ) protocols are being drafted in parallel with hardware architecture. Process validation (PV) planning follows prototype stabilisation. No validation runs have been completed at this stage.
- IQ/OQ architectural planning (ongoing)
- PV protocol structure defined
- Software validation per IEC 62304 framework direction
Design Control Traceability
A requirements traceability matrix (RTM) maps each design input to its corresponding design output, verification activity, and validation evidence. This end-to-end traceability chain ensures no requirement is orphaned during design iterations — a core expectation under ISO 13485:2016 Clause 7.3.
- RTM established through HELIX ONE architecture phase
- Change control log active from prototype stage
- Design review cadence: per milestone
Batch Traceability Architecture
The BiQadx consumables platform proposes a batch traceability concept where every tube, cartridge, disc, and magazine carries a unique batch identifier readable by the instrument system. This architecture concept enables lot-level provenance verification and linkage to instrument run data within the LIMS.
- RFID and QR-code batch ID concept
- Instrument-side lot verification concept
- LIMS batch record integration (planned)
Internal QC & Audit Trail
The Unified LIMS & AI Stack includes architectural provisions for a continuous internal QC monitoring module. Levey-Jennings control chart logic, Westgard rule evaluation, and operator-action audit trails are being designed as core LIMS capabilities — not add-ons.
- Westgard rule engine (R&D concept)
- Per-run QC record linked to batch and operator
- Tamper-evident audit log architecture
Report Verification Portal
A future-state capability concept: a web-accessible portal allowing authorised laboratory administrators to verify report provenance, instrument calibration status, and reagent lot compliance for any historical run. This is a planned capability concept only — no implementation timeline is committed.
- Planned capability — no deployment timeline committed
- Architecture concept: cryptographic report hash
- Role-based access control concept (RBAC)
Regulatory Framework Reference
The following ISO and IEC standards are referenced as architecture targets and framework direction for BiQadx product development. No compliance certifications are held or claimed at this stage.