One platform. Connected PV operations.
Intake, case management, coding, submission, aggregate reporting and signal management — one login, every action audited.
MAHs and PV service providers.
ApplicationsEvery action audited
Across every application
The OnePV applications
Sign in once. Case management, intake, submission, aggregate reporting and signal management share the same identity, master data and audit.
Purpose-built, standalone, in the same family
Validation, e-signature and training — each a HAROM application in its own right.
What HAROM OnePV gives every application
One login
One identity, one launcher, every application.
Workspaces by role
Each role sees its own work.
Master data, once
Products, dictionaries and reference data shared.
Users managed centrally
Joiners, movers and leavers in one place.
Every action audited
Across every application.
E2B(R3) submissions to
Electronic submissions configured, routed and tracked for every authority through HAROM GatewayPRO.
EMA EudraVigilance
European Union
US FDA
ESG · FAERS
UK MHRA
United Kingdom
Health Canada
Canada Vigilance
WHO PIDM
International Drug Monitoring
Standards and formats
Role-based access
Everyone sees exactly what their role allows.
Audit trail on every action
Who, what and when — always on record.
MFA or one-time code, enforced
Every sign-in verified twice.
Strict password policy
Strong, rotated, enforced.
Controlled workflows
Nothing skips a step.
Designed to support 21 CFR Part 11 and EU Annex 11 controls.
A production platform with single sign-on.
Every action audited.
See it working
Walk through HAROM OnePV with a PV expert.