Every case. Controlled. Submitted.
The safety database at the heart of HAROM OnePV — from first report to regulator submission, with control and audit built in.
Case processors, medical reviewers and QA.
The safety case database.
One login with the rest of HAROM OnePV.
Every action audited
Role-based access · controlled workflows
- 1Capture
- 2Code
- 3Review
- 4Submit
Safety Vault v2.0, as your team sees it.
An illustrative view of your workspace.
The safety case database.
Case · Events
Validation gates onReaction (MedDRA PT)
Onset date
Seriousness
Outcome
Listedness
AssessedCausality
AssessedExpectedness
AssessedWorklist
- Data entryIn review
- Medical reviewGate
- SubmissionReady
What Safety Vault v2.0 does
Intake and triage
Every report lands in a controlled worklist.
Validation as you type
Errors caught while the case is built.
MedDRA coding
Reactions, indications and history, coded once.
Assessment built in
Seriousness, listedness and causality, case by case.
Medical-review gate
No case moves on without a reviewer.
Submission-ready outputs
E2B(R3), CIOMS I and MedWatch 3500A from one case.
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.
End-to-end ICSR processing, in production.
Conformance-checked E2B(R3), every time.
See it working
See Safety Vault v2.0 in a live walkthrough with a HAROM PV expert.