Software builders for modern pharmacovigilance
Bright Infonet develops and delivers PVgenix — a modern, GxP-aligned, AI-assisted platform for end-to-end ICSR processing. We build the software; your qualified PV team owns the regulated decisions.
The team behind PVgenix
Bright Infonet is the provider of the PVgenix platform. We build and deliver the application according to each client's requirements and specifications — on current-generation, cloud-native technology rather than decades-old infrastructure.
A substantial part of the platform is already developed. Other features are configured or built fresh depending on the client's requirements, terms, and licensing — so most engagements move from agreed scope to delivery in approximately one month.
Our focus is engineering: a compliant, audit-ready system that accelerates the core ICSR workflow while leaving every regulated judgment in the hands of qualified people.
- We build & deliver the softwareApplication, environment setup & supporting docs
- AI-assisted workflowsIntake & extraction with human-in-the-loop review
- Validation-ready by designIQ/OQ/PQ documentation package to support client validation
- SaaS or dedicatedBoth deployment models from a single codebase
A software provider, with a clear scope
Bright Infonet provides software development only. Drawing that line precisely is part of keeping your safety operations audit-ready.
Software development & delivery
- Platform development & continuous delivery
- Environment setup, hosting & installation
- AI-assisted intake & extraction tooling
- IQ/OQ/PQ documentation & SOP templates
- Data-migration tooling & integration support
A PV or advisory service
- A pharmacovigilance consultancy
- A PV operations or case-processing team
- A business-analysis service
- A regulatory-advisory service
- A licensor of third-party dictionaries
Principles behind the platform
The engineering values that keep PVgenix modern, compliant, and cost-effective for CROs and small-to-mid pharma.
Compliance first
Designed around GxP, GAMP 5, and 21 CFR Part 11 — with full audit logging, RBAC, and a supporting validation documentation set.
Human in the loop
AI accelerates intake and data entry, but qualified people review, edit, and approve before a case proceeds. Regulated judgments stay with your PV team.
Modern by default
Cloud-native, multi-tenant architecture on current-generation frameworks — performance and scalability without legacy server cost.
Audit-ready evidence
Every create, read, update, and delete is captured in a tamper-evident audit trail with electronic-signature support.
Configurable, not custom-locked
No-code workflow, role, and code-list configuration per tenant — so the platform adapts to your SOPs instead of forcing a rebuild.
Cost-conscious delivery
Efficient infrastructure and fast onboarding keep total cost of ownership low — enterprise-grade capability without enterprise pricing.
Clear lines between platform and PV ownership
Bright Infonet develops and delivers the software, environment setup, and supporting documentation. The client and their qualified PV personnel own PV decisions, regulatory interpretation, validation execution, and compliance obligations.
We deliver & operate
- Software development & the deployment model
- Environment setup, hosting & installation
- Validation documentation package (IQ/OQ/PQ)
You decide & validate
- PV decisions & regulatory interpretation
- Validation execution in your environment
- Compliance obligations & regulatory reporting
Third-party dictionaries are client-licensed. Licensed content — including MedDRA and the WHO Drug Dictionary — is procured and licensed by the client. Bright Infonet integrates them into the application but does not supply or license them.
Talk to the team building PVgenix
Request a demo to meet the team and see the platform in action across your intake channels, reporting obligations, and review workflows.