HAROM India
HAROM ValidatePRO
Connected HAROM application

Validation evidence, in one place.

Run OQ, PQ and UAT scripts, attach evidence and results, and generate the VSR and RTM — with full audit traceability from requirement to result. XML QAT included.

QA, validation and PV operations teams — any system, any script.

Prove acceptance before production.

Request a DemoTalk to a PV Expert

A standalone HAROM application, same family, same controls.

HAROM ValidatePRO in use

Every action audited

Role-based access · controlled workflows

  1. 1Plan
  2. 2Execute
  3. 3Evidence
  4. 4Report
Inside the application

ValidatePRO, as your team sees it.

An illustrative view of your workspace.

Prove acceptance before production.

HAROMValidatePROAudit trail on
Test scriptsXML QATRTMReports

Script · OQ

Evidence attachedTraceable
  • Log in with test accountPass
  • Create case from XML importPass
  • Submit to test gatewayPass
  • Verify acknowledgementIn progress
  • Export audit reportPending
Screenshots, logs and results attached to each step

Traceability (RTM)

RequirementTestResult
URS-04OQ · PQ
URS-07OQ · PQ
URS-12OQ · PQ

XML QAT

  • Sent XML + regulator ACKParsed
  • Errors in plain languageFix · re-run
VSR · RTM generated
Reviewer + approver sign-off
What it does

What ValidatePRO does

One universal validation tool: run the scripts, capture the evidence, sign off, report. XML QAT — parsing regulator acknowledgements for ICSR submissions — is one of its key features.

Run any test script

OQ, PQ and UAT executed step by step, in the tool.

Evidence attached

Screenshots, logs and results against each step.

Traceable end to end

Requirement → test → result → sign-off, all audited.

VSR and RTM generated

Validation Summary Report and Traceability Matrix, on demand.

XML QAT

Upload the sent E2B(R3) XML and the regulator ACK; errors in plain language.

Fix, re-run, pass

Rectify, re-check — or mark as passed when the ACK is clean.

Two-step sign-off

Independent reviewer and approver on every outcome.

Compliant reports

Shareable, versioned, inspection-ready.

Standards and formats

OQ · PQ · UATVSR · RTMICH E2B(R3) ICSR and ACK (ICH M2)EMA · FDA · Health Canada acknowledgements
Security controls — the same on every HAROM application

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.

What you can rely on

Scripts, evidence and sign-off in one traceable record.

Regulator acknowledgements explained in plain language.

VSR and RTM generated, not assembled.

See it working

See ValidatePRO in a live walkthrough with a HAROM PV expert.

Request a DemoTalk to a PV Expert