Verixa needed to validate the market and ship a production-ready pharma compliance platform fast — without trading regulatory rigour for speed.
Multiple regulatory frameworks, one coherent platform.
Quality management, electronic records, and inspection preparation each carry distinct requirements under FDA 21 CFR Part 11, EU Annex 11, ICH Q9, and FDA CSA. Bolting them together post-build wasn't an option — the architecture had to satisfy all four from day one.
Validation support engineered in, not retrofitted.
IQ/OQ/PQ template support, change traceability, and controlled documentation were engineered from the start.
Evidence organised for QA review by default.
Audit trails designed for engineers do not survive a regulator's read. Every record is designed to surface in a form that supports QA review and inspection preparation — not reconstructed in a remediation cycle.
Together, these six capabilities form the Verixa compliance platform — a single system regulated pharma teams use for quality management, electronic records, and inspection preparation.
Tamper-evident audit logging with end-to-end traceability, electronic signature support, historical activity visibility, and structured audit workflows that support QA review and inspection preparation — mapped to FDA 21 CFR Part 11 and EU Annex 11 requirements.
Risk-based quality management workflows covering deviation management, CAPA tracking and review, risk classification processes, effectiveness verification, and controlled approval mechanisms aligned to ICH Q9.
Bounded quality workflows (Document Control, Deviation, RCA, CAPA) with configurable, recorded human decision gates between them, per the customer's approved procedure.
Risk-based validation support aligned to FDA CSA principles as a design reference — validation-support templates, controlled test documentation, change traceability, and evidence management. The customer owns intended-use validation.
Granular role-based permissions, controlled workflow approvals, electronic acknowledgement support, user activity traceability, and segregation-of-duty controls.
Centralised compliance dashboards and audit evidence workflows for quality leads and inspectors — running on controlled data ingestion pipelines, secure processing infrastructure, and customer-isolated cloud environments on AWS.
Audit trails, validation evidence, and traceability records are structural requirements, not features. The platform cannot record a controlled event without also generating its inspector-readable evidence.
Following FDA CSA guidance, validation evidence was scoped to the actual risk each component carries to product quality. High-risk components received full IQ/OQ/PQ; lower-risk components received scaled evidence proportional to their risk profile.
Deviation dispositions, CAPA approvals, and controlled workflow sign-offs include human-in-the-loop gates. Automation supports — it does not replace — regulated human judgement.
All audit trails and verification records surface through views designed for quality teams' QA review and inspection preparation.
Dedicated engineering pod against a written SOW under the Sense7Ai MSA, working alongside Verixa stakeholders and domain experts throughout the engagement. Agile delivery with bi-weekly sprint cycles, weekly stakeholder reviews, and validation-focused documentation maintained continuously. Traceability support carried through every sprint output.
StackTypeScript (React + Vite), Node.js with Fastify 5, PostgreSQL + pgvector, AWS secure cloud infrastructure with customer-isolated deployment environments.
The Verixa platform is complete for Phase 1 scope and is in the design-partner stage, pre-validation.
Operational outcomes will be published by Verixa only after verified customer results exist, with written approval.
Detailed timelines and performance data are withheld under confidentiality obligations.
