Frequently Asked Questions

Verixa is a governed-AI workflow platform for regulated life sciences. Customers can begin with a single workflow or connect multiple workflows into a broader quality system. Phase 1 focuses on GMP Core — five workflows, In Design-Partner Validation — with MIRA as a bounded, human-in-the-loop AI assistant.

Verixa can support connected quality management workflows, but customers do not need to purchase or replace an entire quality management system to begin. You can start with a single workflow — such as Document Control or Deviation — and expand the scope as your validation and operational requirements grow.

Yes. Document Control can be scoped as a single workflow, subject to agreed configuration, integration dependencies and the customer-owned intended-use validation scope. Related workflows — such as Deviation or CAPA — can be connected later.

Yes. Verixa is designed so that additional workflows can be connected to an existing deployment — for example, adding RCA and CAPA to an existing Deviation workflow. Scope expansion, configuration, and validation responsibility boundaries are agreed with the customer before connection.

Not necessarily. Verixa is workflow-scoped, not a full platform replacement. Customers define the intended-use boundary — which workflow, which site, which team — and Verixa is deployed within that boundary. Integration with existing LIMS, ERP, or document systems is scoped per deployment.

Navira Quality Systems is the operating entity. Product ownership and intellectual-property rights are governed by the applicable agreements between Navira Quality Systems and its implementation partners. Verixa is the platform. Sense7ai is the implementation partner that built the platform under contract and retains its general engineering IP per an implementation-partner agreement.

Sense7ai is the implementation partner; access to a customer’s tenant data is limited to defined support purposes under the relevant agreements and is covered in the DPA. Tenants are isolated, and customer data is not used to train shared models.

No. Deviation, Root Cause Analysis and CAPA are separate bounded workflows, each with its own steps, human decision gates and record. They connect through recorded handoffs: a qualified-human disposition — governed by your approved procedure — determines whether a deviation initiates RCA, and whether a confirmed root cause initiates CAPA. Each handoff is designed to record who initiated the next workflow, on what basis, and when. You can license one workflow and use it alongside your existing processes, then connect others later under an agreed scope.

It means customer production use has not yet completed intended-use validation under a customer’s own scope. Supplier-side implementation and verification status may differ by workflow and control, and is disclosed for each scoped engagement.

Phase 1 (now, In Design-Partner Validation): GMP Core — Document Control, Deviation, RCA, CAPA and Inspection Readiness, with the Evidence & Validation Pack accompanying every workflow. Phase 2 (2027): quality operations — Findings, Change Control, OOS/OOT, Complaints, Audit & Inspection Management, Supplier Quality, APQR, Batch Records, Stability, Environmental Monitoring, Training, Risk Management and Equipment & Calibration. Phase 3 (2028+): GCP, GVP, GDP and GLP, subject to customer pull.

The founding-partner engagement is a 90 day controlled GMP evidence sprint on one workflow, preceded by a 10-business-day Phase 0 Evidence Mapping. Timelines beyond the founding cohort are scoped per organisation.

Not yet. Those map to GCP, GVP, GDP and GLP, which are Phase 3 (2028+) on the roadmap. Today Verixa is focused on GMP. You can register interest for a Phase 3 domain through the roadmap pages.

Verixa provides controls intended to support applicable 21 CFR Part 11 requirements (e-signature, audit trail, access controls). Compliance itself is a customer determination based on intended-use validation, not a vendor claim — verification of the e-signature substrate is in progress in design-partner validation.

Verixa provides supplier and product-verification evidence for its defined supplier scope, and is currently in design-partner validation. We provide the evidence and templates (the Evidence & Validation Pack) that support your validation; each customer remains responsible for determining applicability and validating or otherwise assuring its configured intended use before production use.

No. MIRA is advisory and human-in-the-loop. MIRA never approves, closes, signs, disposes, or releases a GxP record, and never makes critical GMP decisions (batch release, OOS classification, CAPA disposition). A qualified human accepts, rejects, or modifies every suggestion before it has any GxP impact.

Verixa treats EU GMP Annex 22 (Draft 2025) as an internal-control reference. Consistent with the draft, generative/probabilistic AI is prohibited from making — or being the sole path to — critical GMP decisions in Verixa. Annex 22 is a draft; we track it as it moves toward final.

Verixa makes no claim of EU AI Act compliance. Obligations under Regulation (EU) 2024/1689 are role-specific (provider vs deployer) and obligation-specific (transparency, human oversight, dependence on general-purpose models), and are phasing in through 2026–2027. MIRA is advisory with human-in-the-loop.

Verixa captures AI-assisted decisions as first-class audit-trail objects — model version, prompt hash, retrieved evidence, the human accept/reject/modify decision, and e-signature — an architecture designed to support QA review and inspection preparation. Whether records are suitable for a particular inspection depends on the customer’s intended use, configured workflow, validation or assurance activities, procedures, data-integrity controls and operating practices. Verixa does not determine inspection readiness.

The Evidence & Validation Pack and templates are designed to support your team’s validation of the system for its intended use — supplier assurance, verification evidence and change controls that feed your own validation planning. We don’t publish cost- or effort-reduction figures we can’t yet substantiate; actual customer outcomes will be shared after design-partner validation. The customer still owns intended-use validation.

US tenants are hosted on AWS US-East; India tenants on AWS Mumbai, with DPDP-aware data handling. Tenants are isolated from one another.

Verixa uses Anthropic and Azure OpenAI as AI providers; application data is hosted on AWS. All three are listed as subprocessors in the DPA. Customer data is not used to train shared models, and every inference logs the model name and version, prompt version, retrieval-corpus version, and guardrail version.

You keep a 30-day data export on exit. The deliverables from the engagement — workflow map, evidence pack, configured templates — are yours to keep.

Integration with existing systems (including single sign-on) is scoped with each design partner during Phase 1. Tell us your stack in the application and we’ll map the integration path.

India’s revised Schedule M raises GMP expectations for domestic manufacturers and CDMOs. Verixa Phase 1 GMP Core supports export-quality preparation for India CDMOs facing dual CDSCO and global-client scrutiny, with INR-denominated pricing, AWS Mumbai data residency, and DPDP-aware handling.

The Founding Partner Program is limited to 2 partners by 31 December 2026. Apply through the Founding Partner page (a short qualifying application); a 10-business-day Phase 0 Evidence Mapping precedes the 90 day founding pilot.

Verixa is priced by workflow — not by platform license, module bundle or seat count. You license the workflows you need: a First Workflow License (foundation included), Additional Workflow Licenses, a Connected Workflow Pack, or a Multi-Workflow / Multi-Site Agreement. AI is bundled — no token meter, no overage. A 90-day workflow pilot precedes the annual license, and the pilot fee may be credited toward it, subject to the commercial agreement. See the Pricing page for detail.

Pricing scales by workflow and deployment scope, not by seat count. Multi-site organisations are covered by a Multi-Workflow / Multi-Site Agreement — talk to us through the Pricing or Contact page for a scoped figure.