| Pharmacovigilance science makes use of | | | | technical processes meeting the necessary safety |
| pharmacovigilance software mainly for detecting, | | | | standards. Data entry, reporting, audit trail are some |
| assessing and preventing long term and short-term | | | | of its main features. |
| side effects of medicines. The demand for this kind | | | | The outsourced pharmacovigilance software develops |
| of software is on the rise mainly because of the | | | | drug development expertise, safety rules and |
| withdrawal of several medicines in the markets. This | | | | regulatory necessities, securing client access to data |
| kind of software detects the reasons for this | | | | and regular tracking and status updates to clients or |
| withdrawal and also prevents unwarranted risky | | | | to the authority. It is an economical project |
| happenings in the future. This helps the patients, the | | | | development process making using of the electronic |
| doctors and the manufacturers in the medical world. | | | | medium for handling management purposes. |
| The EMEA or the European Medicines Agency in | | | | The Assured pharmacovigilance software provides |
| Europe develops and maintains the pharmacovigilance | | | | Internet access to the server for the client's use and |
| database of probable serious adverse effect | | | | operation of the system for management and |
| medicines in the market. This system is called Eudra | | | | customer use. This software meets the standards of |
| Vigilance. | | | | pharmaceutical companies, regulatory authorities and |
| Similarly, the US medical society has its own | | | | medical personnel. |
| pharmacovigilance branches namely; the FDA; the | | | | How effective is pharmacovigilance software? |
| academic and non-profit organizations like RADAR | | | | - It minimizes the risk of adverse events (ADR) by |
| and Public Citizen and the pharmaceutical | | | | using genetic profiles. |
| manufacturers. Several companies like Aris Global, | | | | - It makes accurate determinations as to whether a |
| Relsys and Workflow have developed software to | | | | product is safe or not. |
| keep track of safety applications in the market. | | | | - It determines the benefit-risk ratio quickly. |
| Kinds of pharmacovigilance software | | | | - It overcomes the challenges that small firms face |
| PV Works for example is a software system that | | | | as far as limited financial and personnel resources are |
| records report safety data keeping track of adverse | | | | concerned. |
| event reporting. It is a commercial workflow engine | | | | - It helps maintain regulatory compliance and improve |
| providing management control of pharmacovigilance | | | | operational efficiency. |
| processes. Flexible data entry, risk management, | | | | - Global information can be easily shared by means of |
| safety system assessment, evaluation and | | | | this software. In the age of safety concerns, more |
| submission of regulatory reports are some of its | | | | need is being felt for software that can avert |
| important features. | | | | probable risks and also help in worldwide networking |
| PV Works (Vet) is another software system made | | | | in the medical field. Pharmacovigilance software is |
| to support veterinary pharmacovigilance business and | | | | designed just for this. |