Sense7ai

Verixa — AI-enabled compliance platform for regulated pharma

Built for FDA 21 CFR Part 11 · EU Annex 11 · ICH Q9 · FDA CSA validation

Verixa needed to ship a production-ready compliance platform for regulated pharma — fast, and without trading regulatory rigour for speed. Sense7ai partnered as engineering, validation, and delivery partner to design, build, validate, and deploy it.

The platform supports complex compliance workflows across quality management, pharmacovigilance, electronic records, audit readiness, and operational oversight — built on a secure, scalable, enterprise-ready architecture.

At a glance

A Sense7ai ProductLive · production
Engagement
Engineering, Validation & Delivery Partner
Outcome
400+ hrs/mo reclaimed by Clinical QA~2.5 FTEs
Frameworks in scope
FDA 21 CFR Part 11EU Annex 11ICH Q9 (QRM)FDA CSA
Stack
TypeScript (React + Vite)Node.js, Fastify 5PostgreSQL + pgvectorAWS
Controls in scope07
Tamper-evident Audit Trail
Electronic Signatures
IQ/OQ/PQ Validation
CAPA Workflows
Role-Based Access Control
Human-in-loop Review
Inspector-ready Evidence
Constraints

The challenges

Verixa needed to validate the market and ship a production-ready pharma compliance platform fast — without trading regulatory rigour for speed.

CONSTRAINT-01Non-negotiable
REQ

Four regulatory domains, one coherent platform.

NOTE

Quality management, pharmacovigilance, electronic records, and audit readiness 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.

CONSTRAINT-02Non-negotiable
REQ

Validation readiness built in, not remediated in.

NOTE

A platform that becomes validation-ready after deployment is not audit-defensible. IQ/OQ/PQ evidence, change traceability, and controlled documentation had to be engineered from the start — not retrofitted before a regulator visit.

CONSTRAINT-03Non-negotiable
REQ

Inspector-readable evidence by default.

NOTE

Audit trails designed for engineers do not survive a regulator's read. Every record had to surface in inspector-ready form on day one of go-live — not after a remediation cycle.

Six capabilities Sense7ai delivered

Together, these six capabilities form the Verixa compliance platform — a single system regulated pharma teams use for quality management, pharmacovigilance, audit readiness, and inspection workflows.

01

Electronic Records & Audit Traceability

Tamper-evident audit logging with end-to-end traceability, electronic signature support, historical activity visibility, and inspector-ready audit workflows — mapped to FDA 21 CFR Part 11 and EU Annex 11 requirements.

21 CFR Part 11EU Annex 11
Tamper-evident Audit Trail
Electronic Signatures
Inspector-ready Evidence
02

Quality & Risk Management Workflows

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.

ICH Q9
CAPA Workflows
03

Pharmacovigilance Workflow Support

Intelligent safety signal workflows with human-in-the-loop review processes, workflow traceability, review and escalation controls, structured validation documentation, and operational oversight capabilities.

Human-in-the-loopSafety signals
Human-in-loop Review
04

Validation & Compliance Infrastructure

Risk-based validation support aligned to FDA Computer Software Assurance (CSA) principles — validation planning, controlled test documentation, IQ/OQ/PQ execution workflows, change traceability, and evidence management.

FDA CSA
IQ/OQ/PQ Validation
05

Role-Based Access & Approval Controls

Granular role-based permissions, controlled workflow approvals, electronic acknowledgement support, user activity traceability, and segregation-of-duty controls.

RBACE-acknowledgement
Role-Based Access Control
06

Compliance Dashboards & Secure Cloud Infrastructure

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.

AWSCustomer-isolated
Operating tenets

Engineering approach

Compliance infrastructure is first-class architecture

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.

Validation effort is risk-proportional

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.

Human oversight on regulated decisions

Pharmacovigilance signal review, CAPA approvals, and controlled workflow sign-offs include human-in-the-loop gates. Automation supports — it does not replace — regulated human judgement.

Inspector-readable evidence by design

All audit trails and validation records surface through views designed for inspectors and quality leads, not engineering dashboards.

Engagement model

How we worked

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.

Outcomes

Live in 28 weeks. Clinical QA reclaimed 2.5 FTEs from day one.

Program status · Verixa · Live in productionAudited · risk-scaled · evidence-bound

The Verixa platform is live in production, supporting regulated operational workflows for pharma and life sciences use cases. PoC in 6 weeks → MVP 12 weeks later → Production-grade 10 weeks after that.

Clinical QA teams recovered 400+ hours per month — equivalent to approximately 2.5 FTEs.

Those savings come from automated compliance workflows, AI-assisted triage, and structured audit-readiness tooling built into the platform from day one.

Detailed customer-onboarding timelines and operational performance data beyond the above are withheld in accordance with confidentiality obligations.

Frequently asked questions

Is the Verixa platform 21 CFR Part 11 compliant?
Yes. Verixa includes tamper-evident audit logging with end-to-end traceability and electronic signature support, mapped to FDA 21 CFR Part 11 and EU Annex 11 requirements. Every controlled event generates an immutable, inspector-readable record on the same day it occurs.
What regulatory frameworks does Verixa support?
Verixa is built for FDA 21 CFR Part 11, EU Annex 11, ICH Q9 (Quality Risk Management), and FDA CSA (Computer Software Assurance) validation principles. The architecture satisfies all four from day one, not as bolt-on modules.
How long did Verixa take to reach production?
Sequential delivery: proof of concept in 6 weeks, MVP 12 weeks later, and production-grade platform 10 weeks after that — 28 weeks end-to-end. Clinical QA teams recovered 400+ hours per month from day one of go-live, equivalent to approximately 2.5 FTEs.
Does Verixa support IQ/OQ/PQ validation?
Yes. Verixa includes risk-based validation support aligned to FDA Computer Software Assurance (CSA) principles — validation planning, controlled test documentation, IQ/OQ/PQ execution workflows, change traceability, and evidence management. High-risk components receive full IQ/OQ/PQ; lower-risk components receive scaled evidence proportional to their risk profile.
What audit evidence is provided to inspectors?
All audit trails and validation records surface through inspector-readable views by default — not engineering dashboards. Every controlled event generates an immutable record on the day it occurs, surfacing through views designed for regulators and quality leads.

Ready to build your regulated pharma AI platform?

Tell us about the compliance platform you need to ship. Qualified inquiries typically receive a same-day or next-business-day response; scoping calls follow within five business days, subject to availability.

Schedule a scoping callCheck the diligence pack