Assured Information Systems is a leading supplier of workflow-driven pharmacovigilance software to the pharmaceutical industry.

The company’s software products - PV-Works (for human medicines) and PV-Works (vet) (for veterinary medicines) are specifically designed to be operated in compliance with the world-wide regulatory legislation that governs this industry.

Solution: PV-Works

Scope: pharmacovigilance

PV-Works

The functionality of PV-Works ensures that you can capture and report safety data in full compliance with ICH Guidelines. By using the fully integrated workflow functionality, you can be confident that critical reporting deadlines will be met and SOPs will be followed.

PV-Works is a process driven system. The workflow engine, W4, is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

PV-Works (vet)

PV-Works (vet) is a flexible software system designed to support veterinary pharmacovigilance business processes and supporting technical services, whilst meeting the associated company safety and world-wide regulatory reporting requirements.

PV-Works (vet) is a process driven system. The workflow engine, W4, is integrated with comprehensive safety functionality in order to provide management control of pharmacovigilance processes.

Novartis is a world leader in the research and development of products to protect and improve health and well-being.

Their core business is in pharmaceuticals, consumer health, generics, eye-care, and animal health. Their name, derived from the Latin novae artes, meaning "new skills," reflects their commitment to focus on research and development to bring innovative products to the communities they serve.

Novartis has to process around 25 000 cases per year with the obligation to report serious cases in less than 15 days. Since June 2002, a workflow application has been ensuring that all reports support multiple time zones and 'business days'.

Schering-Plough Animal Health is a leading manufacturer and marketer of biologicals, pharmaceuticals and speciality products for animals. Schering Plough Animal Health is a unit of Schering Plough Corporation, a trusted name in pharmaceuticals and health care products worldwide.

Orion Pharma is a business-driven pharmaceuticals company with special emphasis on developing innovative treatments for global markets. Operationally its businesses comprise core therapy areas, speciality products, animal health and fermion.