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PVgenix is a modern, GxP-aligned, AI-assisted pharmacovigilance platform for end-to-end ICSR processing, powered by Bright Infonet. It covers the full safety lifecycle — from multi-channel intake to regulatory submission, signal detection, aggregate reporting, and quality management.

Cases flow from intake through triage, data entry, quality review, medical review, and submission, with duplicate detection, follow-up tracking, and versioning. The platform also includes coding and terminology management, regulatory submission and exchange, literature monitoring, signal detection, aggregate reporting, risk management, reconciliation, and an integrated quality management system.

This describes the platform's overall capability set, not a fixed shipped feature list; scope is defined per client agreement.

AI accelerates intake and data entry — automated extraction from unstructured sources, domain-segmented extraction, AI-assisted narrative generation, and confidence scoring that routes low-confidence items for human review.

AI assists intake and data entry. Qualified personnel review, edit, and approve AI-generated content before a case proceeds; regulated judgments remain with the client's PV personnel.

Configurable straight-through processing is applied only to qualifying, low-risk case types, with rules-based routing, auto-coding, and mandatory review gates for low-confidence items. Human review remains available and is the default for serious or low-confidence cases.

PVgenix runs as a fully hosted multi-tenant SaaS or as a dedicated single-tenant deployment in the client's preferred environment. Both run from a single product codebase for feature consistency.

With SaaS, no. Bright Infonet hosts and manages the platform — there are no servers to procure, no installation, and no DevOps overhead on the client side. A tenant is provisioned from the portal in minutes. Dedicated deployments are set up by our IT team.

They cover IT provisioning and the setup/installation documentation handover only. They are not a full computer system validation timeline and do not include the client's complete validation, qualification execution, SOP authoring, UAT, or PV operational go-live, which are client-led and take additional time.

PVgenix is validation-ready and audit-ready: it ships with a complete IQ/OQ/PQ documentation package to support client-led validation. 'Validated' is a state achieved only after qualification is executed in a specific client environment.

Bright Infonet develops and delivers the software, the environment setup, and the supporting documentation. The client and their qualified PV personnel own PV decisions, regulatory interpretation, validation execution, and compliance obligations.

PVgenix is designed around 21 CFR Part 11, EU GVP modules, GAMP 5, and GxP operational compliance, with full audit logging, RBAC, tenant data isolation, encryption in transit and at rest, and electronic signature capture.

Third-party dictionaries and licensed content - including MedDRA and the WHO Drug Dictionary - are procured and licensed by the client. Bright Infonet integrates them into the application.