The recently implemented EMA regulations have caused our clients to seek out solutions. Fortunately, RxLogix anticipated the need and can solve our clients’ needs today.
Aliso Viejo, CA (PRWEB) July 12, 2012
RxLogix Corporation (http://www.rxlogix.com), the most experienced team of global Safety and Risk Management experts offering consulting services and strategic software solutions, today announced the PV Central Solution for the European Medical Agency (EMA) GVP module II - PV System Master File (PSMF). PV Central was formally introduced in March 2012 at the European Drug Information Association conference in Copenhagen, Denmark.
PV Central provides proactive dashboards and early warning intelligence, including compliance monitoring for Safety and PV Operations management, through an easy to use and intuitive interface including mobile platforms such as the iPhone or iPad. Enabling safety management to have real time information about key global safety metrics including productivity, risk management, and compliance readiness enables an organization to improve accountability and transparency. PV Central key features can help an organization be prepared proactively to take immediate action before significant problems arise. PV Central is available as a hosted solution on the RxLogix SaaS platform for ease of implementation.
The PV Central Solution for PSMF addresses all aspects of regulations in a single concise and easy-to-use interface with real-time access. Key deliverables, as required by the EMA GVP module II, include vital metrics, reports and documentation for:
- PSMF section on qualified person responsible for pharmacovigilance (QPPV)
- PSMF section on the organisational structure of the marketing authorisation holder
- PSMF section on the sources of safety data
- PSMF section on computerised systems and databases
- PSMF section on processes
- PSMF section on pharmacovigilance system performance
- PSMF section on quality system
RxLogix’s European Practice Director and EMA regulations contributor Dr. Peter Nowicki commented, “The development of PV Central took into consideration the importance of accountability, transparency and productivity of Safety and Risk Management teams globally. The PV Central Solution for PSMF takes it a step further, providing direct solutions for the implementation of a PSMF to be in compliance with EMA regulations implemented this month.” Every marketing authorization holder in Europe should seriously consider PV Central as part of their organization’s compliance to EMA regulations. Initial customer briefings with global clients have generated strong interest in PV Central as part of their PSMF plans. RxLogix’s John Loucks, Chief Sales and Marketing Officer, added, “The recently implemented EMA regulations have caused our clients to seek out solutions. Fortunately, RxLogix anticipated the need and can solve our clients’ needs today.”
To arrange a demonstration with the RxLogix’s strategic software solutions, please contact Chief Sales and Marketing Officer John Loucks at +1-570-472-3459 or email john(dot)loucks(at)rxlogix(dot)com.
About RxLogix Corporation
RxLogix Corporation is an experienced team of global Safety and Risk Management experts offering consulting and strategic software solutions. RxLogix has extensive business, domain, regulatory, and IT experience consulting with global leading biopharmaceutical, medical device, and CRO’s. In addition, RxLogix provides strategic software solutions for executive management and key integrations that enhance client productivity while lowering costs. RxLogix is also an Oracle Gold and Certified Argus Safety Partner.
With a global staff of 70+ and headquartered in Aliso Viejo, California, RxLogix has offices in the United States, Europe and Japan. To learn more about the company's products and services, please call +1-570-472-3459 or e-mail info(at)rxlogix(dot)com.