KNOW HALOPV

PHARMACOVIGILANCE PROCESS ORCHESTRATION AND AUTOMATION

HALOPV is designed to help Pharmacovigilance organizations deliver efficient processing of PV activities, across Safety Operations, Safety Surveillance and QPPV / compliance office departments - globally as well as locally.

 

A unique and modular platform for ensuring PV process quality and efficiency through a unique offering of artificial intelligence, integrations, scripting, business process management and robotics process automation in a GxP cloud.

HALOPV MODULES

ICSR

  • Local Intake

  • Progress tracking and workflow compliance

  • Reconciliation with affiliates and partners

  • Follow-up Management

PSMF

  • Manage multible PSMF versions with separate contributors

  • Workflow for each annex

  • Auto-generate annexes, format using word templates

SDEA/PVA

  • Manage agreements with partners and affiliates

  • Auto-generate SDEA  documents, format using word templates

Requirement Intelligence

  • Manage all local requirements and obligations 

  • Auto-build 'reporting rules' and auto-schedule activities according to them

Literature monitoring

  • Track local literature screening compliance

  • Manage sources

  • Setup queries and integrate with literature databases

Aggregate reporting

  • Manage schedules and workflow progress of reports

  • Auto-generate report documents, format using word templates

Risk Management

  • Global risk register

  • Manage risk strategy, risk management, documents, risk minimization measures (also locally) and other activities

Product Management

  • Manage product information across families/groups, products and market/clinical licenses

  • Include active ingredients

Submission Management

  • Submission compliance tracking

  • Handle local submissions

  • Analytics across manual and automated submissions

Quality/Audit/CAPA 

  • Manage audit plans / reports

  • Track CAPA's globally and visualize effectiveness

  • Maintain QMS documents and deviations/ NC's

Data collection programs

  • Easy registration of Market Research, Patient Support, Registries, social media etc

  • Manage Partner Roles

Signal Management

  • GVP Module lX compliant tracking of signal work

  • Track periodic and ad hoc detection activities

INTEGRATIONS

The Latest version of HALOPV (2.2.6) is integrated with your Office 365 Sharepoint/Onedrive  environment. You can edit Word, Excel, Powerpoint documents etc. directly from HALOPV records in workflow and add multiple reviewers.

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