Multi-channel intake
Cases from email, web forms, call notes, partners and literature collected into one queue with duplicate checks.
Regulated software · Drug safety
Pharmacovigilance software that keeps every deadline visible.
Drug-safety case management for marketing authorisation holders, CROs and PV service providers — from the first report to the regulatory submission.
- StandardICH E2B(R3)
- CodingMedDRA (your licence)
- RecordsPart 11 audit trail
- AIPre-read, human-confirmed
Bright Infonet is a Panchkula-based software company that builds pharmacovigilance software: case intake from email, forms and literature, MedDRA coding, medical review, E2B(R3) ICSR generation and submission, and signal management. Part 11 audit trails and e-signatures are built in, and AI can pre-read each case so safety staff review instead of retyping.
Pharmacovigilance is a race against regulatory clocks. Every adverse event report has to be received, checked for validity, coded, assessed and, where required, submitted within a fixed number of days. When cases arrive in inboxes, PDFs and spreadsheets, staff spend their time copying data rather than assessing it.
Our PV software brings intake into one queue, tracks the due date of every case from day zero, and moves it through data entry, MedDRA coding, quality check, medical review and submission. Cases are exported as E2B(R3) ICSR files for the gateways and partners you report to, and periodic data is ready for aggregate reports.
We know this domain because we built PVgenix, our pharmacovigilance SaaS, where AI pre-reads each incoming case and pre-fills the fields for a person to confirm. You can see it described on our work page. For your own system, we reuse that experience in a build shaped around your SOPs.
Case workflow
From first report to submission.
Validity & triage
Minimum criteria checked, seriousness and expectedness assessed, and the reporting clock started on day zero.
MedDRA coding
Events and indications coded with your licensed MedDRA version, and products against your product dictionary.
QC and medical review
Second-person data checks and medical assessment with causality, narrative and electronic sign-off.
E2B(R3) submission
ICSR XML generated and validated against the E2B(R3) format, with acknowledgements tracked per receiver.
Follow-ups
Follow-up information versioned against the original case, with resubmission when the changes require it.
Oversight
Compliance you can see at a glance.
Due-date dashboard
Every open case with its regulatory deadline, so late submissions are prevented rather than explained.
Signal management
Case series, disproportionality views and a tracked process for validating, prioritising and closing signals.
Aggregate report data
Line listings and summary tabulations for periodic reports, drawn from the same validated case data.
Audit trail & signatures
Every change to a case recorded with user, time and reason, and approvals signed electronically.
AI with a human check
AI suggests fields and codes from source documents; a qualified person confirms every suggestion.
Partner exchange
Case exchange with licensing partners and service providers under the timelines in your agreements.
Is this for you?
A good fit if…
- Your safety team tracks cases in spreadsheets and email and worries about missed deadlines.
- You are a PV service provider handling several clients and need one controlled system.
- A commercial safety database is too expensive or too heavy for your case volume.
- You want AI to speed up case entry without removing human review.
FAQ
Common questions.
What does pharmacovigilance software do?
It manages individual case safety reports from intake to regulatory submission: validity checks, coding, assessment, reporting deadlines, E2B files and audit trails. Many systems also support signal detection and aggregate reports.
What is E2B(R3)?
E2B(R3) is the ICH standard for exchanging individual case safety reports electronically. Regulators such as the FDA and EMA accept ICSRs in this format through their gateways.
Do we need our own MedDRA licence?
Yes. MedDRA is licensed through its maintenance organisation, so the subscription stays with your company. The software loads the version you are licensed for and handles version upgrades.
Can AI be used in pharmacovigilance case processing?
Yes, as an assistant. AI can read source documents and suggest case fields and codes, but a qualified person must review and confirm, and the system must log what the AI suggested.
Should we build pharmacovigilance software or buy it?
Buy when a commercial safety database fits your volume and budget; build when your process, partners or cost structure do not fit. Our build-or-buy guide walks through the trade-offs.
Is the system validated?
We deliver it with a GAMP 5 validation pack and Part 11 controls. Your QA reviews, executes where required and approves the validated state.
Keep reading
Related pages.
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