OEM Partner: Assured
Assured Information Systems is a leading supplier of BPM driven pharmacovigilance software for the pharmaceutical industry.
The company’s software products - PV-Works (for humans) and PV-Works (vet) (for veterinary medecine) are specifically designed to be in compliance with worldwide 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 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 W4 engine is integrated with comprehensive security 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, while meeting the associated company security and worldwide regulatory reporting requirements.
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 of reporting serious cases in less than 15 days. Since June 2005, a workflow application ensures 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 pharmaceutical company with special emphasis on developing innovative treatments for global markets. Operationally, its business includes therapy areas, speciality products and animal health.

